Inspections, Compliance, Enforcement, and Criminal Investigations
7-10 - ATTACHMENTS, EXHIBITS, AND APPENDIX
Note: For each recall action, the RES provides a single record that is initiated at the beginning of the recall with an Alert. The record is continually updated in order to provide information for the Recall Recommendation, Classification, FDA website posting, any updates, and finally, Termination. The RES requires submission of some information not previously required. As the RES is finalized, detailed instructions will be provided for district and center coordinators. At the present time, the information provided or requested in the following attachments remains pertinent and appropriate for all steps of the recall process.
A Recall Alert Information(PDF - 49KB) B Recommendation for Recall Classification(PDF - 70KB) B1 Recommendation for Recall Classification and Termination(PDF - 53KB) C Recall Termination or Recommendation for Termination(PDF - 50KB) D Health Hazard Evaluation Worksheet(PDF - 66KB) D1 21 CFR Part 7, Guidance to Health Hazard Evaluation Committees(PDF - 64KB) 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)(PDF - 66KB) F Recalls of Infant Formula(PDF - 50KB) G Recalls of Medical Devices, Section 518(e)(PDF - 70KB) H Methods for Conducting Recall Effectiveness Checks(PDF - 57KB) I Mandatory Recall of Tobacco Products(PDF - 56KB)
7-1 Model Effectiveness Check Letter (Industry)(PDF - 51KB) 7-2 Model Effectiveness Check Response Format (Industry)(PDF - 40KB) 7-3 Model Effectiveness Check Questionnaire for Telephone or Personal Visits (Industry)(PDF - 41KB) 7-4 Model Recall Letter (Generic, All Centers)(PDF - 55KB) 7-5 Model Recall Return Response Form(PDF - 87KB) 7-6 Model Recall Envelope(PDF - 49KB) 7-7 Model Notification of Classification Letter (FDA to Recalling Firm)(PDF - 57KB) 7-8 Model Ineffective Recall Letter(PDF - 50KB) 7-9 Model Recall Termination Letter(PDF - 50KB) 7-10 Model Combined Recall Notification of Classification and Termination Letter(PDF - 51KB) 7-11 Request for Audit Check Format(PDF - 40KB) 7-12 Audit Check Report Instructions/Explanation By Section(PDF - 41KB) 7-12A Audit Check Report(PDF - 40KB) 7-13 Weekly Class I Recall Status Report (Optional)(PDF - 54KB)