Regulatory Procedures Manual Chapter 7: RECALL PROCEDURES This chapter contains the following sections: Section Topic Page 7-1 PURPOSE ............................................................................................................. 4 7-2 BACKGROUND ..................................................................................................... 4 7-3 SUMMARY OF FDA RESPONSIBILITIES AND PROCEDURES .......................... 5 7-3-1 Responsibilities of the Office of Strategic Planning and Operational Policy/Division of Enforcement/Recall Operations Branch (OSPOP/DE/ROB) ............ 6 7-3-2 Responsibilities and Procedures – ORA/Office of Partnerships and Operational Policy (OPOP) .......................................................................................... 6 7-3-3 Responsibilities and Procedures – Office of Information Systems Management/ Division of System Solutions (DSS) /Enforcement Systems Branch ..... 6 7-4 RECALL ENTERPRISE SYSTEM ......................................................................... 6 7-4-1 Enforcement Report ........................................................................................ 7 7-5 INITIATION OF A RECALL .................................................................................... 7 7-5-1 Firm Initiated Recalls ...................................................................................... 8 7-5-2 FDA Requested Recall ................................................................................. 13 7-5-3 FDA Mandated and Ordered Recalls ............................................................ 14 7-5-4 Removals and corrections involving products exported from the U.S. and products imported to the U.S. .................................................................................... 18 7-6 RECALL CLASSIFICATION AND STRATEGY .................................................... 22 7-6-1 Health Hazard Evaluation ............................................................................. 22 7-6-2 Classification Process ................................................................................... 23 7-6-3 Recall Strategy.............................................................................................. 24 7-7 NOTIFICATIONS AND PUBLIC WARNING ........................................................ 25 7-7-1 Reports and Reporting Procedures ............................................................... 25 7-7-2 Notification to Other Government Agencies .................................................. 28 7-7-3 Public Warning .............................................................................................. 30 7-8 RECALL MONITORING ....................................................................................... 33 7-8-1 Background ................................................................................................... 33 MAN-000010 Page 1 of 153 VERSION 10 Regulatory Procedures Manual July 2021 Chapter 7 Recall Procedures 7-8-2 Managing FDA’s Recall Audit Check (RAC) Strategy ................................... 33 7-8-3 Requesting and Reviewing Recall Status Reports Requesting and Reviewing Recall Status Reports ................................................................................................ 40 7-8-4 State Audits .................................................................................................. 40 7-9 RECALL TERMINATION ..................................................................................... 41 7-10 ATTACHMENTS, EXHIBITS, AND APPENDIX ................................................... 42 ATTACHMENTS: ....................................................................................................... 43 EXHIBITS: ................................................................................................................. 44 APPENDIX: ............................................................................................................... 45 Attachment A – Recall Alert Information .................................................................... 46 Attachment B – Recommendation for Recall Classification ....................................... 48 Attachment B1 – Recommendation for Recall Classification and Termination .......... 53 Attachment C – Recall Termination or Recommendation for Termination ................. 54 Attachment D – Health Hazard Evaluation Worksheet .............................................. 55 Attachment D1 – 21 CFR Part 7, Guidance to Health Hazard Evaluation Committees . ...................................................................................................................... 58 Attachment E – Recalls Of Radiation Emitting Electronic Products Under Subchapter C - Electronic Product Radiation Control Of Chapter V Of The Federal Food, Drug, And Cosmetic Act (The Act), Formerly The Radiation Control For Health And Safety Act Of 1968 (RCHSA) ................................................................................................ 62 Attachment F – Recalls of Infant Formula .................................................................. 66 Attachment G – Recalls of Medical Devices, Section 518(e) ..................................... 67 Attachment H – Methods for Conducting Recall Effectiveness Checks ..................... 72 Attachment I – Mandatory Recall of Tobacco Products ............................................. 74 Attachment J – Mandatory Recall Authority for Foods ............................................... 76 Attachment J1 – Recommendation Memorandum ..................................................... 88 Attachment J2 – Notification of Opportunity to Initiatiate a Voluntary Recall ............. 89 Attachment J3 – Prehearing Order to Cease Distribution and Give Notice ................ 91 Attachment J4 – Denial of Hearing Request .............................................................. 93 Attachment J5 – Hearing Report Cover Letter ........................................................... 94 Attachment J6 – Hearing Report................................................................................ 95 Attachment J7 – Vacated Order ................................................................................ 96 Attachment J8 – Amended Order .............................................................................. 97 Attachment J9 – Modified Order ................................................................................ 98 Attachment J10 – Mandatory Food Recall Process Flow Chart ................................. 99 MAN-000010 Page 2 of 153 VERSION 10 Regulatory Procedures Manual July 2021 Chapter 7 Recall Procedures Attachment K – Notification, Nondistribution, and Recall of Controlled Substances for Human or Animal Use .............................................................................................. 100 Attachment K1 – Order of Nondistribution ............................................................... 110 Attachment K2 – Hearing Report Cover Letter ........................................................ 111 Attachment K3 – Hearing Report ............................................................................. 112 Attachment K4 – Vacated Order of Nondistribution ................................................. 113 Attachment K5 – Continued order of Nondistribution ............................................... 114 Attachment K6 – Amended Order to Include Recall ................................................ 115 Attachment K7 – Notification, Nondistribution, and Recall of Controlled Substances for Human or Animal Use Process Flow Chart ........................................................ 116 Attachment L – Models for Standardized Recall Audit Check (RAC) Levels and Effectiveness of the Recall Notification System for Human Food Recalls ............... 117 Attachment M – Medical Device Safety Alerts ......................................................... 122 Exhibit 7-1 Model Effectiveness Check Letter (Industry) ......................................... 123 Exhibit 7-2 Model Effectiveness Check Response Format (Industry) ...................... 124 Exhibit 7-3 Model Effectiveness Check Questionnaire for Telephone or Personal Visits (Industry) ........................................................................................................ 126 Exhibit 7-4 Model Recall Letter (Generic, All Centers) ............................................. 128 Exhibit 7-5 Model Recall Return Response Form .................................................... 130 Exhibit 7-6 Model Recall Envelope .......................................................................... 132 Exhibit 7-7 Model FDA Requested Recall Letter ..................................................... 133 Exhibit 7-8 Model Acknowledgement (to be used when RES automated email request cannot be used due to the RES not functioning or the firm not having an email address) ................................................................................................................... 135 Exhibit 7-9 Model Notification of Classification Letter (FDA to Recalling Firm) ........ 138 Exhibit 7-10 Model Recall Ineffective Recall Letter .................................................. 139 Exhibit 7-11 Model Recall Termination Letter .......................................................... 140 Exhibit 7-12 Model Combined Recall Notification of Classification and Termination Letter ...................................................................................................................