Recall & Complaint History – Required cGMP Records for Inspection & Importer Requests
Under 21 CFR Part 111, dietary supplement manufacturers and brand owners are required to maintain recall and consumer complaint records. These documents may be reviewed during FDA inspections or requested by importers, private label clients, and major retail platforms to verify compliance with quality and safety standards.
Who Needs It?
- • Manufacturers & Contract Packers of dietary supplements
• Private Label Brands working with third-party suppliers
• Importers & Distributors asked to verify supplier history
• Amazon/Walmart Sellers submitting compliance records
• FSVP Agents conducting supplier verification
Why It’s Required:
- • Mandated by 21 CFR Part 111.553–111.570
• Confirms systems are in place for handling consumer complaints and product recalls
• Reviewed during FDA audits, supplier verifications, and importer due diligence
• Required for good manufacturing practices and traceability
What’s Included:
- • FDA-Compliant Complaint & Recall Record Templates
• Log Formats for Product Complaints and Corrective Actions
• Recall Action History Template
• Categorization Guidance (adverse events, quality issues, labeling concerns)
• Optional Add-on: SOP for Complaint & Recall Handling
• Final PDF + Editable Version Ready for Internal and Client Use
What’s Included:
- • FDA Facility Registration (New or Renewal)
• U.S. Agent Appointment (for foreign facilities)
• Registration Confirmation and Number
• Biennial Renewal Reminders & Monitoring
• FDA Compliance Guidance & Support
Pricing:
| Service | Standard Price | Support360 Member Price (50% Off) |
|---|---|---|
| Recall & Complaint History Documentation | $100 | $50 |
- Support360 Members receive 50% OFF all FDA documentation tools and templates.
Why It Matters:
- Without proper documentation, your brand may face:
- • FDA 483s or warning letters for missing or incomplete records
• Rejection by importers or distributors requesting safety documentation
• Removal from Amazon or retail platforms during compliance reviews
• Inability to defend or manage quality incidents
