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This report is generated for a subscriber who monitors Marine Collagen Powder. When the FDA takes action affecting that ingredient, they get this — not a generic headline.
Marine Collagen Powder
FDA CFSAN Warning Letters · 21 CFR 111.75(a)(1)(ii)
FDA Action
Warning Letter WL-2025-CFSAN-0847 — NovaBiotics Inc. (Oct 14, 2025). Identity testing failures for marine-sourced collagen.
Analysis
NovaBiotics failed to confirm the identity of marine collagen concentrate through appropriate laboratory testing prior to use. The FDA cited missing ingredient-specific identity tests — COA-only documentation was deemed insufficient.
Required Actions
- 1Audit your identity testing protocols for marine collagen against 21 CFR 111.75(a)(1)(ii)
- 2Verify COA documentation includes marine collagen-specific identity tests, not just generic protein analysis
- 3Confirm with your contract manufacturer that identity tests are performed per batch, not per lot
What free subscribers see
FDA Updates Identity Testing Requirements for Marine-Sourced Supplements — Oct 14, 2025
No product match. No action items. No analysis.
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