Certificate of Analysis (COA) – Proof of Product Integrity
A Certificate of Analysis (COA) is a required document under 21 CFR Part 111 for dietary supplements marketed in the U.S. It confirms that your product is tested for identity, potency, purity, and safety, ensuring full compliance with FDA regulations and buyer expectations.
Who Needs It?
- • Dietary Supplement Manufacturers producing finished goods
• Private Label Brands sourcing from contract manufacturers
• Importers & Distributors entering the U.S. market
• eCommerce & Retail Sellers listing products on Amazon, Walmart, etc.
Why It’s Required:
- • Verifies that each batch meets label claims and quality specifications
• Confirms identity of ingredients and absence of contaminants
• Required for FDA cGMP compliance under 21 CFR Part 111
• Requested by third-party platforms, retailers, and auditing bodies
• Demonstrates transparency and traceability in your supply chain
What’s Included:
- • Custom COA Template Development
• Final Product Testing Spec Guidance
• Supplier COA Verification Checklist
• Batch Documentation & Testing Log Tools
• Support for Identity, Potency, Microbial, and Heavy Metal Parameters
• Guidance on Choosing Third-Party Accredited Labs
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) |
|---|---|---|
| COA Setup & Compliance Package | $1,500 | $750 |
- Support360 Members receive 50% OFF on all documentation and compliance setup services.
Risks of Missing or Invalid COAs:
- Without recognized certification, your brand may be:
- • FDA enforcement during inspections
• Product delisting from Amazon, Walmart, and other platforms
• Buyer rejections and delayed shipments
• Loss of brand credibility and retailer trust
