Product Recalls, Removals, and Corrections: Procedures and Best Practices
This guidance provides recommendations to FDA-regulated industry regarding product recalls, removals, and corrections. It covers both voluntary and mandatory recalls for all FDA-regulated products including medical devices, drugs, biologics, food, cosmetics, and tobacco products. The guidance details what information firms should provide to FDA and how to notify customers about product recalls.
Recommended Actions
- Establish internal procedures for recall decision-making and execution
- Create templates for recall communications and documentation
- Maintain up-to-date distribution records and customer contact information
- Develop recall effectiveness check procedures
- Train relevant personnel on recall procedures and responsibilities
- Establish communication protocols with FDA Division Recall Coordinator
- Create procedures for product quarantine, return, and destruction
- Implement system for tracking recall status and preparing reports
- Develop procedures for root cause analysis and corrective actions
- Establish criteria and procedures for recall termination
Key Considerations
Labelling
- Recall communications should be clearly marked as “URGENT: [PRODUCT TYPE] RECALL”
- Include complete product description and identification codes
- Provide clear instructions for product handling and return
- Include product labels in recall communications when helpful for identification
Safety
- Provide detailed health hazard assessment associated with the violation
- Explain how the violation affects product performance and safety
- Include detailed information on complaints and adverse events
- Document root cause analysis and corrective actions
Other considerations
- Submit recall information to FDA as soon as decision is made to recall
- Establish communication with FDA Division Recall Coordinator
- Provide complete distribution information and customer lists
- Conduct effectiveness checks to verify recall communications were received and followed
- Submit monthly recall status reports to FDA
- Maintain proper documentation of product destruction or reconditioning
- Ensure recall reaches appropriate depth in distribution chain
- Obtain FDA concurrence before terminating recall
Relevant Guidances
- Distinguishing Between Medical Device Recalls and Device Enhancements
- Public Warning and Notification of Recalls Under Part 7
Related references and norms
- 21 CFR Part 7: Enforcement Policy
- 21 CFR Part 806: Medical Device Reports of Corrections and Removals
- 21 CFR Part 810: Medical Device Recall Authority
- 21 CFR Part 1003: Notification of Defects (Electronic Products)
- 21 CFR Part 1004: Repurchase, Repairs, or Replacement of Electronic Products
Original guidance
- Product Recalls, Removals, and Corrections: Procedures and Best Practices
- HTML / PDF
- Issue date: 2020-03-02
- Last changed date: 2024-10-01
- Status: FINAL
- Official FDA topics: Radiation-Emitting Products, Tobacco, Medical Devices, Food & Beverages, Dietary Supplements, Drugs, Animal & Veterinary, Biologics, Cosmetics, Recalls
- ReguVirta summary file ID: da06159fab661896a3a54f8992d22266
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