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Compliance Program 7371.000 FOOD AND DRUG ADMINISTRATION COMPLIANCE PROGRAM GUIDANCE MANUAL PROGRAM 7371.000 CHAPTER 71: POST APPROVAL MONITORING OF ANIMAL DRUGS, FEEDS, AND DEVICES SUBJECT: IMPLEMENTATION DATE: COMPREHENSIVE ANIMAL FOOD INSPECTION 02/08/2021 DATA REPORTING PRODUCT CODES PRODUCT/ASSIGNMENT CODES (PAC) USE APPROPRIATE PRODUCT CODES REPORT PROGRAM ACTIVITIES UNDER THE FOLLOWING PAC CODES: FDA PACs 71004 MEDICATED FEED MANUFACTURING CGMP INSPECTIONS - LICENSED FACILITIES 71009 BSE INSPECTIONS 71012 MEDICATED FEED MANUFACTURING CGMP INSPECTIONS – NON-LICENSED FACILITIES 71014 PART 507 CGMP INSPECTIONS 71015 PART 507 CGMP/PC INSPECTIONS 71016 MODIFIED REQUIREMENTS INSPECTIONS AT ANIMAL FOOD QUALIFIED FACILITIES 71017 MODIFIED REQUIREMENTS INSPECTIONS AT ANIMAL FOOD STORAGE FACILITIES SOLELY ENGAGED IN UNEXPOSED PACKAGED FOOD THAT REQUIRE TIME/TEMPERATURE CONTROLS FOR SAFETY 71018 ANIMAL FOOD SANITARY TRANSPORTATION INSPECTIONS 71023 VETERINARY FEED DIRECTIVE INSPECTIONS 71030 ANIMAL FOOD FD&C ACT INSPECTIONS 71R894 ANIMAL FOOD RISK-DATA FORM Transmittal Number: 2021-CPGM-CVM-001 Date of Issuance: 02/08/2021 Page 1 of 120 PROGRAM 7371.000 STATE PACs 71S004 STATE CONTRACT MEDICATED FEED MANUFACTURING CGMP INSPECTIONS – LICENSED FACILITIES 71S011 STATE CONTRACT BSE INSPECTIONS 71S012 STATE CONTRACT MEDICATED FEED MANUFACTURING CGMP INSPECTIONS – NON- LICENSED FACILITIES 71S014 STATE CONTRACT PART 507 CGMP INSPECTIONS 71S015 STATE CONTRACT PART 507 CGMP/PC INSPECTIONS 71S016 STATE CONTRACT MODIFIED REQUIREMENTS INSPECTIONS AT ANIMAL FOOD QUALIFIED FACILITIES 71S017 STATE CONTRACT MODIFIED REQUIREMENTS INSPECTIONS AT ANIMAL FOOD STORAGE FACILITIES SOLELY ENGAGED IN UNEXPOSED PACKAGED FOOD THAT REQUIRE TIME/TEMPERATURE CONTROLS FOR SAFETY 71S018 STATE CONTRACT ANIMAL FOOD SANITARY TRANSPORTATION INSPECTIONS 71S023 STATE CONTRACT VETERINARY FEED DIRECTIVE INSPECTIONS 71S894 STATE CONTRACT ANIMAL FOOD RISK- DATA FORM FIELD REPORTING REQUIREMENTS: Establishment inspection reports (EIRs) must be completed in eNSpect per Investigations Operations Manual (IOM) subchapter 5.11 Establishment Inspection Report (EIR). Investigational reports must be prepared per IOM subchapter 8.10 General Investigation Reporting. Corrective actions taken during an inspection must be documented in the Observations and Corrective Action Reporting (OCAR) system – Corrective Action Report (CAR) within eNSpect. Compliance activities must be performed as outlined in the Regulatory Procedures Manual (RPM). Division recommendations coupled with their supporting evidence for a compliance action or actions should only be submitted to the Center for Veterinary Medicine (hereafter CVM or the Center) using Compliance Management Services (CMS) database. Transmittal Number: 2021-CPGM-CVM-001 Date of Issuance: 02/08/2021 Page 2 of 120 PROGRAM 7371.000 Contents Glossary ........................................................................................................................................................ 8 PART I – BACKGROUND ........................................................................................................................ 10 1. Summary of Comprehensive Inspection Model .............................................................................. 10 2. Summary of Food Facility Registration, Medicated Feed Mill Licensing and Registration, and Veterinary Feed Directive Distributor Notification Requirements ......................................................... 11 3. Summary of PCAF Requirements (21 CFR part 507) .................................................................... 11 4. Summary of Medicated Feed Current Good Manufacturing Practice (CGMP) Requirements (21 CFR part 225) ......................................................................................................................................... 12 5. Summary of Veterinary Feed Directive Requirements (21 CFR §558.6) ....................................... 13 6. Summary of Prohibited Materials in Ruminant Animal Food (BSE) Requirements (21 CFR §§589.2000 and 589.2001) ..................................................................................................................... 13 7. DIRECTED ONLY: Summary of Sanitary Transportation Requirements (21 CFR part 1, subpart O) 13 8. Summary of Adulteration and Misbranding Provisions for Facilities not Subject to Specific Animal Food Safety Regulations (21 U.S.C. §§342 and 343) ................................................................ 14 PART II - IMPLEMENTATION ................................................................................................................ 15 1. Objectives ....................................................................................................................................... 15 2. Program Management Instructions ................................................................................................. 15 A. Inspection Priorities .................................................................................................................... 15 B. Comprehensive Inspection Priorities .......................................................................................... 16 C. Selection of High and Low Regulatory Priority Facilities .......................................................... 16 D. Comprehensive Inspection Frequency ........................................................................................ 19 E. Planning Instructions .................................................................................................................. 20 F. Program Interactions ................................................................................................................... 21 G. Interactions with Federal Agencies, State and Local Counterparts, and Foreign Authorities .... 24 H. FDA Notifications ....................................................................................................................... 26 PART III - INSPECTIONAL ..................................................................................................................... 29 1. Operations ....................................................................................................................................... 29 A. Inspections .................................................................................................................................. 29 B. Investigations .............................................................................................................................. 43 C. Sample Collections ..................................................................................................................... 43 D. Documentary Sample Collections ............................................................................................... 43 E. Import Activities ......................................................................................................................... 44 F. Other ........................................................................................................................................... 44 2. Reporting......................................................................................................................................... 44 Transmittal Number: 2021-CPGM-CVM-001 Date of Issuance: 02/08/2021 Page 3 of 120 PROGRAM 7371.000 PART IV – ANALYTICAL ....................................................................................................................... 46 1. Analyzing Laboratories ................................................................................................................... 46 2. Analyses to be Conducted ............................................................................................................... 46 3. Methodology ................................................................................................................................... 46 4. Reporting......................................................................................................................................... 46 PART V - REGULATORY/ADMINISTRATIVE STRATEGY ............................................................... 47 1. Findings........................................................................................................................................... 47 A. Regulatory Significance .............................................................................................................. 47 B. Classification ............................................................................................................................... 48 C. Factors to Consider ..................................................................................................................... 49 2. Charges ........................................................................................................................................... 49 A. Adulteration ................................................................................................................................ 49 B. Misbranding ................................................................................................................................ 53 C. Prohibited Acts ............................................................................................................................ 56 3. Actions ...........................................................................................................................................
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