This Document Represents a Draft Recall Plan Workbook for Participants to Use in Developing
Total Page：16
File Type：pdf, Size：1020Kb
This document represents a Draft Recall Plan Workbook for participants to use in developing a recall plan and program for their individual farms.
RECALL PLAN FOR ______FARM
This plan addresses the Code of Federal Regulations (CFR), Title 21, Subpart C, Section 7.
“Recall is an effective method of removing or correcting consumer products that are in violation of laws administered by the Food and Drug Administration.”
Adapted from Small Scale Food Producers Association (https://www.ssfpa.net/) University of Florida (http://edis.ifas.ufl.edu/pdffiles/FS/FS10800.pdf) The Food Recall Manual
Created by Diane T. Ducharme, NCSU GAP Program Coordinator ([email protected]) March 2016; with adaptations by Ginger Nickerson, UVM Extension, March 9, 2016 Table of Contents
Introduction …………………………………………………………………………………………. 3
Scope
Recall Policy
General Recall Information ……………………………………………………………………… 3 Why Initiate a Recall What is a Recall Types of Recall Classes Mock Recall Recall Team
Regulatory Specifics ………………………………………………………………………………… 6
Recall Procedure………………………………………………………………………………………. 7 Recall Procedure Flow Diagram
Recall Plan Checklist………………………………………………………………………………… 10
Appendices: Appendix A: Customer/Buyer Contact list Appendix B: Recall Team Appendix C: Produce Traceability & Mock Recall (SOP) Appendix D: Recall Log Appendix E: Example of Information Collected from Consumer Appendix F: Action Log Appendix G: Information for FDA Local Coordinator Appendix H: Traceability Log Appendix I: Model Recall Notification (via Phone) Appendix J: Model Recall Notification Letter Appendix K: Sample Press Release Appendix L: Product Retrieval Log Appendix M: Model Recall Return Response Form Appendix N: Model Recall Envelope Appendix O: Model Effectiveness Check Response Format (Industry) Appendix P: Model Effectiveness Check Questionnaire For Telephone Or Personal Visits (Industry) Appendix Q: Model Effectiveness Check Letter (Industry) Appendix R: Request for Recall Termination Appendix S: Restoration Plan Appendix T: Potential Items for Restoration Plan Appendix U: Communications Log
2 Appendix V: Resources to Contact in Case of Recall
References/Resources
3 1. Introduction Fill in this section with . Mission statement for your farm . Provide a summary of the acreage, produce, and distribution chains.
Scope This plan outlines the procedures and forms to use on ______Farm for a recall, market withdrawal or mock recall in accordance with 21 CFR Part 7, Subpart C: (21 CFR 7.40-59) Recalls (Including Product Corrections) – Guidelines on Policy, Procedures, and Industry Responsibility: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm? CFRPart=7&showFR=1&subpartNode=21:1.0.1.1.6.3.
U.S. Food and Drug Administration (FDA) have authority over most other foods, including produce. It is the FDA’s Guidance for Industry: Product Recalls, Including Removals and Corrections (http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129259.htm) that is being used to help fulfill FDA’s plans in handling all aspects of a product recall, including all corrections and removals and to facilitate the development of this plan. Recall Policy
In the event that a food safety issue arises with our products ______Farm will protect public health by facilitating the efficient, rapid identification and removal of unsafe food from the distribution chain and, by informing consumers (where necessary) of the presence in the market of a potentially hazardous food.
There is a documented recall procedure in place and this will be periodically tested to ensure that it is comprehensive and fit for purpose in its ability to remove an unsafe product from consumers and/or the distribution chain.
General Recall Information Why Initiate a Recall Product recall is initiated for two reasons: 1. Removal from markets to protect public from products that may cause health problems or possible death 2. Removal of mislabeled product (false or misleading labeling and/or packaging)
What is a Recall 4 Recall are the procedures conducted to identify and recover potentially adulterated, misbranded, and/or hazardous foods from trade and/or consumer channels effectively. Recalls can be voluntary actions by manufacturers. Manufacturers and/or distributors may initiate a recall at any time to fulfill their responsibility to protect the public health from products that present a risk of injury or gross deception, or are otherwise defective. Firms may also initiate a recall following notification of a problem by FDA or a state agency, in response to a formal request by FDA, or as ordered by FDA. Under FDCA section 423(a), FDA is required to first give a responsible party the opportunity to cease distribution and conduct a voluntary recall of an article of food. If the responsible party refuses to or does not voluntarily cease distribution or recall such food within the time and in the manner prescribed by FDA, FDA may proceed under the mandatory recall authority as set forth in FDCA section 423. FDA does have the authority to seize adulterated products or to acquire an injunction against distribution or may initiate recall process by informing firm of adulterated product in commerce has been identified. An effective recall program will protect company employees and brand names from adverse legal, regulatory and publicity actions. “Natural” occurrences of food contamination have been documented but prevention is far from 100% achievable! This means preventing purposeful contamination as well. This is also part of an effective traceability program.
2. Types of Recall Classes (See Appendix A: Food Recall Terms) Class 1: a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death. Examples of this are: . Listeria monocytogenes, . Salmonella, . E. coli O157:H7 Class 2: a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Examples of this are: . Hard/sharp foreign objects 7 – 25 mm . Undeclared yellow 5 & 6 . Unapproved/uncertified colors . Shigella, staph toxin . Undeclared wheat Class 3: a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences. Examples of this are: • Mold, yeast, lactobacillus • Hard/sharp foreign objects less than 7 mm • Off odor/off taste from contaminant at levels not likely to pose a hazard to health Market Withdrawal: Occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. An examples of this is:
5 • a product removed from the market due to tampering, without evidence of manufacturing or distribution problems Mock Recall A mock recall involves a simulated recall exercise for both your farm and your markets. This is done on a periodic basis, annual if GAP certified, to evaluate the effectiveness of your plan and procedures. The process should mimic your actual recall plan. Mock recalls are used to determine whether the recall procedure is capable of identifying and quickly controlling a given lot of potentially affected product and reconciling the quantities produced, quantities in inventory, and quantities distributed. A mock recall will identify potential problems and allow personnel to become familiar with recall procedures. If problems are identified in the recall procedures, they should be corrected.
Recall Team It is important to have a team responsible for traceability. The Team is responsible for co-ordinating all aspects of the product recall. A recall coordinator is to be appointed and members of a recall team identified from the various functional areas. Together the team will assist the Recall Coordinator in the event of the recall. All members must ensure that all procedures are carried out effectively and efficiently. The team is to receive appropriate training so that they understand their responsibilities. The Recall Management Team list shall be updated at least four times a year to ensure all names, contact phone numbers and responsibilities of team members and alternates are updated. For your local recall coordinator, please check the following website: http://www.fda.gov/Safety/Recalls/IndustryGuidance/ucm129334.htm For the Northeast Region (New England District) this includes Vermont, Maine, Massachusetts, New Hampshire, Rhode Island, Connecticut, and New York, the recall coordinator is: Susan Liner & Pamela Ogonowski Recall Coordinators One Montvale Avenue, 4th Floor Stoneham, MA 02180 Phone: 781-587-7481 (S. Liner) Phone: 781-587-7449 (P. Ogonowski) Fax: 781-587-7556 [email protected] Regulatory Specifics
According to the 21 CFR Part 7, the recall strategy will take into account the following factors:
1. Results of health hazard evaluation. 2. Ease in identifying the product. 3. Degree to which the product's deficiency is obvious to the consumer or user. 4. Degree to which the product remains unused in the market-place. 5. Continued availability of essential products.
FDA will review the adequacy of a proposed recall strategy developed by the recalling firm and recommend changes as appropriate (more below). 6 A recall strategy will address the following elements regarding the conduct of the recall: (1) Depth of recall. Depending on the product's degree of hazard and extent of distribution, the recall strategy will specify the level in the distribution chain to which the recall is to extend, as follows: (i) Consumer or user level, which may vary with product, including any intermediate wholesale or retail level; or (ii) Retail level, including any intermediate wholesale level; or (iii) Wholesale level. (2) Public warning. The purpose of a public warning is to alert the public that a product being recalled presents a serious hazard to health. It is reserved for urgent situations where other means for preventing use of the recalled product appear inadequate. The Food and Drug Administration in consultation with the recalling firm will ordinarily issue such publicity. The recalling firm that decides to issue its own public warning is requested to submit its proposed public warning and plan for distribution of the warning for review and comment by the Food and Drug Administration. The recall strategy will specify whether a public warning is needed and whether it will issue as: (i) General public warning through the general news media, either national or local as appropriate, or (ii) Public warning through specialized news media, e.g., professional or trade press, or to specific segments of the population such as physicians, hospitals, etc. (3) Effectiveness checks. The purpose of effectiveness checks is to verify that all consignees at the recall depth specified by the strategy have received notification about the recall and have taken appropriate action. The method for contacting consignees may be accomplished by personal visits, telephone calls, letters, or a combination thereof. A guide entitled "Methods for Conducting Recall Effectiveness Checks" that describes the use of these different methods is available upon request from the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. The recalling firm will ordinarily be responsible for conducting effectiveness checks, but the Food and Drug Administration will assist in this task where necessary and appropriate. The recall strategy will specify the method(s) to be used for and the level of effectiveness checks that will be conducted, as follows: (i) Level A--100 percent of the total number of consignees to be contacted; (ii) Level B--Some percentage of the total number of consignees to be contacted, which percentage is to be determined on a case-by-case basis, but is greater that 10 percent and less than 100 percent of the total number of consignees; (iii) Level C--10 percent of the total number of consignees to be contacted; (iv) Level D--2 percent of the total number of consignees to be contacted; or (v) Level E--No effectiveness checks. As soon as the decision to initiate a recall has been determine, the local FDA District Recall Coordinator will be contacted. This is prior to issuance of press or written notification to customers.
7 Recall Procedure
This procedure states the action/s ______Farm will take to effectively manage the recall of a food which has been determined to be unsafe or unsuitable. A recall plan outlines the flow, procedures and necessary documents to gather or fill in.
8 Recall Procedure Flow Diagram Source: http://www.fooddecisionsoftware.com/food_recall_template_downloads
9 Sources: http://www.fooddecisionsoftware.com/food_recall_template_downloads
10 11 Recall Plan Checklist Before a Recall Create a Customer/Buyer Contact list (Appendix A). Be sure to update names, phone numbers, and emails annually or as needed. . Restaurants or CSA company: Two contacts in purchasing/shipping department . Your own CSA: All members by email or website . Farmer’s Market/Roadside stand: Website for customers to look for information, email sign up sheet, signs posted at the market or roadside stand Create a Recall Team and Contact list (Appendix B). This list should include names and phone numbers of media, representatives, proper authorities (FDA, NCDA, etc.), your insurance company, and your legal council. Effective Produce Traceability and Recall procedures and Log (Appendix C & D) have been demonstrated.
A problem has been identified (chemical, physical, or microbial risks) from a consumer complaint, regulator notification, and internal operations discovery or laboratory reports.
Activate the Recall Team to collect and assess the health risks (Example of Consumer Information shown in Appendix E)
Collect information, as needed to address issue. Some examples: o List of suppliers of product o Inventory of product – on site, shipped, to retail consumers o Compliant logs o Compliance records (e.g., inspections, labs) o Production logs (e.g., equipment maintenance logs, packing specs, and product specs.) o Distribution and storage logs o Employee complaints, sickness or other
Document with a written log (Appendix F) of dates, times, attendees of any related event or action.
Determine actionable items: Is this a recall? Market withdrawal? Or handled internally by correction (repairing, relabeling or other adjustments to product), stock recovery (hold on merchandise still under your control)? (Appendix F)
Stop production and distribution
Instruct management & employees to not discard any product
12 Recall Decide o Contact local FDA Coordinator addressing intent o Collect information to specific (Appendix G)
Perform traceback procedures to determine the product (s), Number of units, units of measure, farm, harvest date, and lot numbers involved (one commodity, or one day all commodities, etc.) (Appendix H)
Collect pertinent documentation regarding the affected product . Inputs and outputs of affected field associated with the lot number such as notes on flooding, wildlife activity, ill employees, manure application, etc.
You will need to determine the traceforward (Appendix D)
Work with your FDA Local Coordinator and media to initiate necessary recall notice and press release. (Appendices I - N) Do a recall assessment. Determine the percent effectiveness of the recall. (Appendices O-Q) Determine if the recall is over, Recall termination (Appendix R) Upon completion of the recall, outline and issues in the recall plan and how you should change the recall plan to make it better o Root Cause Analysis – Ask WHY? Until you get to the root cause (Appendix S) Restoration plan from the recall (Appendices S & T)
13 3. Appendix A: Customer/Buyer Contact list
Customer/Bu Address Email Business Mobile Product yer Name Phone Phone Sold
14 15 Appendix B: Recall Team *Core-team members ROLE NAME BUSINESS AFTER HOURS RESPONSIBILITIES PHONE PHONE DURING RECALL *CEO/Operation Team leader Manager/Owner Decision Making Obtain/Notify Legal Alternate:______Counsel *Production Contacting Manager Production/Distribution/ other Accounts Alternate:_____ Technical Advisory *Quality Quality Assurance / Assurance Technical Advisory Manager Complaint Investigation Health Departments Contact Coordinates (microbial) sample evidence
*Publicity & Public Media Communication Relations Coordinate with work staff messages Marketing/advertising changes *Attorney Handles liability questions and federal and state responses Scientific Advisor Speaks to health & food safety aspects Administrative Assist with paperwork/ Support documentation, etc. State Department Coordinate of Health resources/communication FDA Local Recall Notification to FDA of Coordinator a recall actions Insurance Address any insurance Representative policies & documentation a FDA Local Recall Coordinator: Contact as soon as a decision is made that a recall is appropriate and prior to the issuance of press or written notification to customers. It is recommended that you do not wait to submit this information until ALL applicable information is prepared and assembled prior to FDA notification. This "early"
16 notification will allow FDA the opportunity to review and comment on your written notification and to offer guidance and assistance in your recall process.
17 Appendix C: Produce Traceability & Mock Recall (SOP) SAMPLE LANGUAGE FOR TRACEABILITY PLAN This is sample language. You will need to re-write it so that it is appropriate for what you do at your farm.
TRACEABILITY Our traceability and recall programs are closely related. Trace back records Our farm utilizes a traceability system that allows us to trace product one step forward and one step back. We keep records of all of our agricultural inputs including soil amendments, fertilizers, seeds/transplants, and agricultural chemicals so that we can link them with each of our crop types and ultimately, if necessary, to the buyer(s). [DESCRIBE YOUR SYSTEM HERE – THIS IS AN EXAMPLE – YOUR SYSTEM AND THE INFORMATION YOU RECORD MAY BE DIFFERENT]
1. All products produced by the farm will be assigned a traceability code (Lot number) based on harvest date, crop, and field number. 2. Harvested product will be tagged, stamped or labeled by marketing unit (Examples: bin, box, case, pallet, bag, etc.) to show the following information: a. The type of crop The name and address of our farm b. The field the crop was grown in [IF APPLIES] c. The harvest date [OR PACK DATE- WHICHEVER YOU USE ON YOUR LABELS] d. The lot number [IF USED] e. 3. All product is invoiced as it is shipped from the farm. 4. Invoices include: farm name and information, buyer name and information, and inventory amounts transferred/ exchanged. 5. Invoice should be signed or initialed by the customer (receiving party) when product is delivered. 6. All unused/unsold inventories is accounted for including quantity, date and method of disposal.
We use a lot number system that identifies the harvest date and field (Example: 072414-2 means harvested on July 24, 2014 from field 2. Adding any other information that you use in your lot tracking system.) When we make a sale, the invoice includes information on boxes shipped, to whom, the date of shipment, and the harvest date and field code number. We keep copies/have electronic copies of all invoices so that the buyer and we have the same information. If a product is comingled during or after harvest, the above label information for EACH crop type and block of land is provided to the buyer.
Trace forward and mock recalls exercise Once during each growing season, we conduct a trace forward/mock recall exercise to verify that we can match each lot sold to the specific buyer and that we can recall product if needed. As part of the exercise, we contact a buyer to identify 18 a load received from our company. We ask how much of the product has been sold, how much they have in inventory and if any has been disposed for other reasons (fell on floor, etc.). This information is recorded on our Mock Recall form and kept on file (document). We keep a record of contact information for each of our buyers (document). After a selected lot is sold and shipped, we go through our records to verify that we can match each box shipped to each buyer it was shipped to. Our goal is to achieve 100% effectiveness of reconciliation of product to recipients within ___ hours. The percent effectiveness of the recall is calculated in the following way:
A= total amount of product B= amount still in inventory C= amount delivered to customers D = incidental usage if any (e.g. product dropped on ground, etc.…) (B+C+D) / A x 100 = % effectiveness of recall
The goal of the exercise is to demonstrate that we have open communication pathways with our buyers and that, should it be necessary, we can work with our buyers to remove any of our shipped products from their inventory.
19 Appendix D: Traceability/Mock Recall Log
Date: Buyer/Customer name: Buyer contact info:
Amt. Produc ID/L Harve Shi Shipped Date & Amt. of Amt. of Amt. of Initials t ot # st p & Time Product Product product Date PO # Buyer Remaini Sold by returned Dat Indicate e Contact ng in Buyer / container ed Buyer to Who destroye type Possessi d on
Comments: Determine the percent effectiveness of the (mock) recall The total amount of suspect product must equal the sum of the product shipped and the amount still in inventory.
A – total amount of product produced B – Amount still on inventory C – Amount delivered to customers D – Incidental usage (product dropped on ground, etc.)
* This recall Log is used for EACH buyer AND one for company’s on-premises inventory (not distributed & in storage).
20 Appendix E: Example of Information Collected from Consumer This form is available at: http://edis.ifas.ufl.edu/pdffiles/FS/FS10800.pdf
Source: http://edis.ifas.ufl.edu/pdffiles/FS/FS10800.pdf
21 Appendix F: Action Log This checklist is designed to be a general “log of actions” that includes all major actions and requirements. It may easily be adapted in greater detail to a company’s specific Recall Plan. You can download a clearer version from: http://edis.ifas.ufl.edu/pdffiles/FS/FS10800.pdf
22 Source: http://edis.ifas.ufl.edu/pdffiles/FS/FS10800.pdf
23 Appendix G: Information for FDA Local Coordinator As soon as the decision to initiate a recall has been determine, the local FDA District Recall Coordinator should be contacted. This is prior to issuance of press or written notification to customers. FDA recommends the inclusion of the following information in your recall submission: 1. PRODUCT INFORMATION: Product name (include brand name and generic name) Description of the product o Include if product is powder, liquid, tablet, capsule, etc. o Include the intended use or indications. o If the product is perishable, include the expected shelf life. o Include type of packaging (i.e. box, flexible plastic, glass). o TWO COMPLETE SETS OF ALL labeling to your Local FDA District Recall Coordinator. Include: o Product labeling (including ALL private labels) o Individual package label o Case label (photocopy acceptable) o Package Inserts o Directions for Use o Promotional Material (if applicable)
2. CODES (Production Identification Numbers): Lot/Unit Numbers (NOTE: If "all lots" are involved or the product is not coded, explain how non-recalled, or reintroduced product may be distinguished from product subject to recall. Provide an explanation of your lot number coding system.) Expiration date(s) or Use by date(s) or Expected shelf life of product. UPC codes
3. RECALLING FIRM: Firm name, address, city, state, zip code Identify firm type (i.e. manufacturer, importer, broker, repacker, own-label distributor) CONTACTS for Recalling Firm:
o Name/title/phone/fax number/e-mail address for RECALL contact o Name/title/address/phone/fax number of the most responsible individual for the recalling firm o Name/title/phone/fax number/e-mail address for public contact
24 4. MANUFACTURER (if applicable)
o Firm name, address, city, state, zip code o FDA registration number, if applicable
5. IDENTIFY FIRM RESPONSIBLE FOR THE VIOLATION/PROBLEM:
o Firm name, address, city, state, zip code
6. REASON FOR THE RECALL:
o Explain in detail how product is defective and/or violative.
o Explain how the defect affects the performance and safety of the product.
o If the recall is due to the presence of a foreign object, describe the foreign objects' size, composition, hardness, and sharpness.
o If the recall is due to the presence of a contaminant (cleaning fluid, machine oil, paint vapors), explain level of contaminant in the product. Provide labeling, a list of ingredients and the Material Safety Data Sheet for the contaminant.
o If the recall is due to failure of the product to meet product specifications, provide the specifications and report all test results. Provide copies of any sample analysis.
o If the recall is due to a label/ingredient issue, provide and identify the correct and incorrect label(s), description(s), and formulation(s).
o Please explain how the problem occurred and the date(s) it occurred.
o Explain how the problem was discovered and the date discovered.
o Please explain if the problem/defect affects ALL units subject to recall, or just a portion of the units in the lots subject to recall.
o Explain why this problem affects only those products/lots subject to recall.
o Provide detailed information on complaints associated with the product/problem: . Date of complaint . Description of complaint -include details of any injury or illness . Lot Number/Serial Number involved o If a State agency is involved in this recall, identify Agency and contact.
7. HEALTH HAZARD ASSESSMENT:
o Please provide your assessment of the health risk associated with the deficiency. NOTE: A recall decision does not depend solely on the health risk of the product. Defective products and misbranded products where no health hazard exists are still in violation of the law and should be recalled.
25 8. VOLUME OF RECALLED PRODUCT:
o Total quantity produced o Date(s) produced o Quantity distributed o Date(s) distributed o Quantity on HOLD by Recalling firm and its distribution centers. o Indicate how the product is being quarantined o Estimate amount remaining in marketplace . distributor level . retail level o Provide the status/disposition of marketed product, if known, (e.g. used, used in further manufacturing, or destroyed).
9. DISTRIBUTION PATTERN:
o Number of DIRECT accounts (customers you sell directly to) by type, for example: . wholesalers/distributors . repackers . manufacturers . consumers (direct, internet or catalog sales) . state or federal government consignees . foreign consignees (specify whether they are wholesale distributors, retailers or users) o Geographic areas of distribution, including foreign countries.
o Provide a consignee list (names/address/city/state/contact name/phone number) to the local District Recall Coordinator. Be sure to include any foreign (including Canadian) customers and federal government consignees (USDA agencies, Veterans Affairs, Department of Defense)
o Indicate what the consignee list represents (i.e. all customers who were shipped recalled product; all customers who were sold recalled product; all customers who may have been shipped or sold recalled product because it was sold to them within the applicable time period.)
o Was product sold under a government contract? If yes, provide contract number, contract date and implementation date. If no, indicate so.
o Was product sold to any federal, state, or local agency involved in the school lunch program? If yes, list the consignees and provide quantity and sale and shipment date. In addition, it is recommended that you notify both "ship to" and "bill to" customers of the recall so that
o "Ship to" customers retrieve the product from their location. o "Bill to" customers, if responsible, initiate the subrecall.
26 10. RECALL STRATEGY:
o Indicate the level in the distribution chain to which you are extending the recall. (i.e. wholesale/retail/pharmacy/medical user) If your recall only extends to the wholesale/distributor level, we recommend that you explain your rationale for not recalling to retail/pharmacy level.
o Indicate the method of notification (i.e. mail, phone, facsimile, e-mail). It is advisable to include a written notification so customers will have a record of the recall and your instructions.
o Indicate how letters will be sent to customers (e.g. overnight mail, first class mail, certified mail, facsimile)
o If initial notification is by phone, provide a copy of the phone script to FDA.
o If you have a web site, you should consider posting the recall notification on the web site as an additional method of recall notification. (Note: This is not recommended as a sole means of customer notification.)
o Report on what you have instructed customers to do with the recalled product.
o It is helpful for recalling firms to know the name and title of the Recall Contact for each of its consignees. Addressing a recall notification letter to a recall contact will expedite the recall process and reduce the potential for the notification letter to get misdirected.
o If product is to be returned, explain the mechanics of the process.
o Explain if this recall will create a market shortage that will impact on the consumer.
o Report on recall effectiveness check strategy. Include your actions for non- responders. See:
o Determine and provide your course of action for out-of-business distributors.
o Provide a proposed method of destruction, if applicable.
o If the product is to be "reconditioned", explain how and where the reconditioning will take place. Please provide details of the reconditioning plan to your local FDA District Recall Coordinator before implementation. All reconditioning must be conducted under any applicable CGMPs.
o Describe how reconditioned product will be identified so it is not confused with recalled (pre- reconditioned) product.
In addition, we recommend that:
o You contact your local FDA District Recall Coordinator prior to product destruction. FDA will review your proposed method of destruction and may choose to witness the destruction.
o The recalling firm and customers keep adequate documentation of product destruction (and whether or not destruction was witnessed by an FDA investigator).
o Field corrections, (i.e. product relabeling), be performed by recalling firm representatives, or under their supervision and control. It is not recommended that a disinterested party such as a
27 wholesaler or retailer be responsible for field corrections. For Drug Recalls: Misbranded drugs for re-labeling should be returned to the recalling firm.
o You contact your local District Recall Coordinator prior to release of reconditioned goods.
28 Appendix H: Traceability Log
SHIPPED TO Product: Lot Number/ Lot Name/Location: Date Quantity Quantity Shipped Code/Date: Quantity: Shipped: Left On- and Requiring Farm: Recovery:
TOTAL=
29 Appendix I: Model Recall Notification (via Phone) The following information is to aid you when contacting people to recall your product. Fill out one sheet for each group contacted. This is (Name of Recall Coordinator)______.
I am calling from (Your Operation’s Name) ______to notify you that all product (Lot #)______on (Date/Time) ______needs to be returned, destroyed, modified, etc.______.I have the following questions to ask you about this recall:
1. Who do I speak to about a recall and what is their contact information?
Contact (Name): ______
Phone Number: ______
Fax Number: ______
Title: ______
2. Do you have any of the product(s) being recalled? (If no, terminate questioning.) YES / NO
If the answer to question #2 is YES, the product must be returned, destroyed, modified, etc. ______
3. The return, destruction, modification, etc. of this product will be dealt with by action intended: ______
4. Have you received any reports of illness or injury related to this product? YES / NO
If YES, please provide details. ______
______
Confirmation Signature: ______Date: ______
30 31 Appendix J: Model Recall Notification Letter
Index of Generic Model Letter Exhibits in FDA Regulatory Procedures Manual
4. Salmonella Model Press Release FOR IMMEDIATE RELEASE COMPANY CONTACT AND PHONE NUMBER DATE
FOOD CO. RECALLS PRODUCT BECAUSE OF POSSIBLE HEALTH RISK Company Name of City, State is recalling Quantity and/or type of Product, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. Product was distributed Listing of states and areas where the product was distributed and how it reached consumers (e.g., through retail stores, mail order, direct delivery). Specific information on how to identify the product (e.g., the type of container [plastic, metal, glass], size and appearance of the product, the product's brand name, flavor, code and expiration date, etc.). Status of the number of and types of related illnesses that have been CONFIRMED to date (e.g., "No illnesses have been reported to date."). Brief explanation about what is known about the problem, such as how it was revealed, and what is known about its source. An example of such a description -- "the recall was as the result of a routine sampling program by the company which revealed that the finished products contained the bacteria. The company has ceased the production and distribution of the product as FDA and the company continue their investigation as to what caused the problem." Information on what consumers should do with the product and where they can get additional information (e.g., "consumers who have purchased Brand X are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-XXX-XXXX.)
Source: Industry Guidance Information on Recalls of FDA Regulated Products (Last Update: 12-14-2011) http://www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm
32 Appendix K: Sample Press Release Index of Generic Model Letter Exhibits in FDA Regulatory Procedures Manual ( SAMPLE PRESS RELEASE) XYZ Inc. 123 Smith Lane Anywhere, MS FOR IMMEDIATE RELEASE Sam Smith /555-555-5555 DATE XYZ RECALLS "SNACKIES" BECAUSE OF POSSIBLE HEALTH RISK XYZ Inc. of Anywhere, MS, is recalling its 5 ounce packages of "Snackies" food treats because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis. The recalled "Snackies" were distributed nationwide in retail stores and through mail orders. The product comes in a 5 ounce, clear plastic package marked with lot # 666666 on the top and with an expiration date of 12/12/99 stamped on the side. No illnesses have been reported to date in connection with this problem. The potential for contamination was noted after routine testing by the company revealed the presence of Salmonella in some 5 ounce packages of "Snackies." Production of the product has been suspended while FDA and the company continue their investigation as to the source of the problem. Consumers who have purchased 5 ounce packages of "Snackies" are urged to return them to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-XXX-XXXX.
Source: Industry Guidance Information on Recalls of FDA Regulated Products (Last Update: 12-14-2011) http://www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm
33 Appendix L: Product Retrieval Log
Quantity Date/ Time Person Quantity Recovered Q Action Taken and Quantity Recovered: Shipped and Contacted: or Destroyed: u Description (e.g., picked Requiring a up, returned, destroyed, Recovery n etc.): t i t y
R e m a i n i n g
W i t h
C o n t a c t : TOTAL = (Total to equal the total on Form 2) Appendix M: Model Recall Return Response Form Index of Generic Model Letter Exhibits in FDA Regulatory Procedures Manual NOTE: This MODEL is intended to serve as guidance for recalling firms. It may not conform to your firm's recall strategy. Please make any appropriate modifications to the response form. IT IS ADVISABLE TO SUBMIT THE PROPOSED RECALL LETTER AND RESPONSE FORM TO YOUR LOCAL FDA RECALL COORDINATOR FOR REVIEW, PRIOR TO ISSUANCE.
PLEASE FAX COMPLETED RESPONSE FORM TO Tel. # < >, ATTN: < > OR MAIL TO: FIRM NAME AND ADDRESS Appendix N: Model Recall Envelope Index of Generic Model Letter Exhibits in FDA Regulatory Procedures Manual
FIRST CLASS MAIL
JOHN DOE Somewhere, U.S.A. 12345
A. B. C. Retail Company Anywhere, U. S. A.
(red print) URGENT: RECALL
Source: Industry Guidance Information on Recalls of FDA Regulated Products (Last Update: 12-14-2011) http://www.fda.gov/Safety/Recalls/IndustryGuidance/ Appendix O: Model Effectiveness Check Response Format (Industry) Index of Generic Model Letter Exhibits in FDA Regulatory Procedures Manual
Consignee Name and Address
(Pressure Sensitive Label)
Recall Effectiveness
Checks-Mail Method JOHN DOE PRODUCT RECALL ______PLEASE READ EACH QUESTION AND CHECK THE PROPER ANSWER YOU HAVE CHOSEN. PLEASE CHECK WITH ANYONE WHO MAY HAVE RECEIVED THIS NOTIFICATION BEFORE ANSWERING. DATE______
1. Did your firm receive notification that the John Doe Company is recalling its ______(Name)______product? YES_____ NO_____
2. Did your firm receive shipments of the product being recalled? (If no, please sign and return). YES_____ NO______
3. Do you now have any of the recalled product on hand? (Please check inventories before answering). YES______NO______
4. If the answer to question 3 is YES, do you intend to return the product to the John Doe Company as requested? YES______NO______
5. If the answer to question 4 is NO, please explain your intentions. 6. Have you received any reports of illness or injury related to this product? YES______NO______If yes, please provide details.
Name of person completing questionnaire:______
Source: Industry Guidance Information on Recalls of FDA Regulated Products (Last Update: 12-14-2011) http://www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm Appendix P: Model Effectiveness Check Questionnaire For Telephone Or Personal Visits (Industry) Consignee Name and Address (Pressure Sensitive Label) JOHN DOE PRODUCT RECALL
After contacting the consignee and locating the person responsible for handling recall notifications and/or the product involved, an opening similar to the following may be used.
This is (Name of Interviewer). I am calling for (recalling firm) to check on the effectiveness of the company recall of (product description, including codes). On (date), (recalling firm) notified (how: letter, telephone, visit, mailgram, etc.), all firms which may have purchased (product) that all stock should be (returned, destroyed, modified, relabeled, etc.). I have the following questions to ask you about this recall:
DATE______
1. Did your firm receive notification that (product name) products manufactured by John Doe Company are being recalled? YES______NO______2. Did your firm receive shipments of the product being recalled? (If no, terminate questioning and go to the closing). YES______NO______3. Do you have any of the recalled product on hand? (Please check inventories before answering). YES______NO______4. If the answer to question 3 is YES, do you intend to return the product to the John Doe Company as requested? YES______NO______5. If the answer to question 4 is NO, please explain your intentions ______6. Have you received any reports of illness or injury related to this product? YES______NO______If yes, please provide details.
Thank you for your cooperation. And your name is ______And what is your title please?______Interviewer______Date______
IF RESPONDENT HAS ANY FURTHER QUESTIONS, ASK HIM/HER TO CONTACT THE JOHN DOE COMPANY, SOMEPLACE, SOMEWHERE 12345
Source: Industry Guidance Information on Recalls of FDA Regulated Products (Last Update: 12-14-2011) http://www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm Appendix Q: Model Effectiveness Check Letter (Industry)
NOTE: If this letter is sent to distributors who may have further sold the product to other distributors or to retail outlets, the third paragraph should include the fact that the recall notice requested the direct consignees to conduct sub-recalls by notifying their customers of the recall situation.
Consignee Name and Address Date
(Pressure Sensitive Label)
Dear Sir:
On (date), you were notified by letter that John Doe Company, Someplace, Somewhere 12345, is recalling (product name), container size, code number. All products were manufactured by John Doe Company and distributed solely under the manufacturer’s label.
Recall of the product was initiated following [INSERT YOUR EXPLANATION FOR WHY PRODUCT WAS RECALLED]
The recall notice from John Doe Company requested consignees (wholesalers and retailers) to discontinue selling their existing stock of the old formulations and return existing inventories of the recalled formulations to John Doe Company.
In order to advise the Food and Drug Administration about the effectiveness of this John Doe Company recall, you are requested to complete and return the enclosed questionnaire promptly using the prepaid self-addressed envelope.
If you have any questions or problems with this request, please call (name and telephone number).
Thank you for your cooperation. Sincerely,
Source: Industry Guidance Information on Recalls of FDA Regulated Products (Last Update: 12-14-2011) http://www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm Appendix R: Request for Recall Termination This form is available at: http://edis.ifas.ufl.edu/pdffiles/FS/FS10800.pdf Appendix S: Restoration Plan
1. Why was there a recall? (E.g., What was the source of the problem?)
______
______
______
2. What corrective action(s) was/were taken? (List and describe)
______
______
______
3. What ongoing procedures did you put in place to prevent the recurrence of the problem?
______
______
______
4. Identify the person(s) responsible for ensuring the above actions and procedures are monitored and implemented.
______
______
______
Confirmation Signature:______Date: ______Appendix R: Potential Items for Restoration Plan Source: GA Department of Agriculture Appendix U: COMMUNICATIONS LOG
Company or Contact By By In Recall Team Copy Reason or Organization Phone Email Person Member on Description File Appendix V: Resources to Contact in Case of a Recall Vermont Department of Health Main Number - Call: 802-863-7200 In Vermont 800-464-4343 http://healthvermont.gov/contact/contact.aspx Elisabeth Wirsing Program Chief Food & Lodging Program [email protected] Address: 359 South Park Drive Colchester, Vermont 05446 Phone: 802-338-4724 Fax: 802-338-4706 Emergency: 802-863-7200
Vermont Agency of Agriculture (802) 828-2430 [email protected] Kristina Sweet Vermont Agency of Agriculture, Food, and Markets [email protected] (802) 522-7811
Food and Drug Administration For the Northeast Region (New England District) this includes Vermont, Maine, Massachusetts, New Hampshire, Rhode Island, Connecticut, and New York, the recall coordinator is: Susan Liner & Pamela Ogonowski Recall Coordinators One Montvale Avenue, 4th Floor Stoneham, MA 02180 Phone: 781-587-7481 (S. Liner) Phone: 781-587-7449 (P. Ogonowski) Fax: 781-587-7556 [email protected]
UVM Extension Produce Safety Programs GAPs and Produce Safety Coordinator Ginger Nickerson [email protected] 802-656-5459
CAPS – Community Accredited Produce Safety Hans Estrin [email protected]
Grower Associations Vermont Vegetable and Berry Association http://www.uvm.edu/vtvegandberry/?Page=WelcomeVVBGA.html
NOFA- VT and Vermont Organic Farmers Address: 39 Bridge St, Richmond, VT 05477 Phone:(802) 434-4122
Testing labs – see separate sheet in back of manual
Media WCAX Burlington, VT 05406-4508. Primary Phone: 802-652-6300. Primary email: [email protected]. Vermont Public Radio (802) 655-9451 http://www.vpr.net/inside_vpr/contact_us/
Times Argus 802-479-0191 General Number 802-223-3931 Vermont Press Bureau
Vermont Digger Anne Galloway, executive director of Vermont Journalism Trust and editor of VTDigger, can be reached at: 802-225-6224 (office) 802-222-6086 (google voice) 802-595-9159 (mobile) [email protected]. press releases and commentaries to [email protected] References/Resources:
5. US Code of Federal Regulations Title 21 http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm? CFRPart=7&showFR=1&subpartNode=21:1.0.1.1.6.3
Model Press Release Guidance is available on the FDA website at: http://www.fda.gov/Safety/Recalls/IndustryGuidance/default.htm FDA DISTRICT RECALL COORDINATORS A current list of FDA recall coordinators can be found on FDA’s website at: http://www.fda.gov/Safety/Recall/IndustryGuidance/ucm129334.htm The Food Recall Manual – IFAS(FSHN – 04-10) https://edis.ifas.ufl.edu/fs108
California Public Health Dept Recall Template: https://www.cdph.ca.gov/pubsforms/Documents/fdbRIgde23.pdf