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From: Policy Canary <alerts@policycanary.io>
Your Marine Collagen Powder — Action Required
March 4, 2026 · 7:14 AM
Marine Collagen Powder
The FDA cited three companies for identity-testing failures on marine-sourced collagen in the last 90 days. Your product's ingredient profile matches the cited substances. Lab protocols need updating.
Action Items
- Verify identity-testing protocols for marine collagen
- Request updated CoA from supplier
- Document compliance review for FDA inspection readiness
Deadline
Q2 2026
Source
21 CFR 111.75(a)(1)(ii)
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From: Policy Canary
Your Marine Collagen Powder — Action Required
Marine Collagen Powder
Identity-testing warning mapped to your ingredient profile.
Action required by Q2 2026
21 CFR 111.75(a)(1)(ii)
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Monitored Products
Marine Collagen Powder
BHA Eye Cream SPF 15
Biotin Complex 5000mcg
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Monitored Products
Marine Collagen Powder
NovaBiotics failed identity testing for marine collagen. COA-only documentation was deemed insufficient by the FDA. Your product uses the same ingredient — this warning applies to your formulation.
Recommended Actions
- 1Audit identity testing protocols against 21 CFR 111.75(a)(1)(ii)
- 2Verify COA includes marine collagen-specific identity tests, not generic protein analysis
- 3Confirm per-batch testing with your contract manufacturer
Action required by Q2 2026
Source: FDA CFSAN Warning Letters · 21 CFR 111.75(a)(1)(ii)
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WEEKLY INTELLIGENCE
The FDA This Week
Jul 13–Jul 17, 2026
FDA enforcement centered on Foreign Supplier Verification Program (FSVP) failures and critical CGMP violations in sterile pharmaceutical manufacturing facilities. Device and pharma leads should monitor Class I recalls for surgical convenience kits containing recalled Huons-manufactured lidocaine and bupivacaine. Safety alerts identified hidden prescription drugs, including tapentadol and meloxicam, in products marketed for pain relief and immune support.
Deadline: 2024-04-26
View Source ↗Convenience Kit Recall: B. Braun Medical, Inc. Removes Spinal Anesthesia Kits Containing Huons Bupivacaine Hydrochloride in Dextrose Injection, USP
B. Braun Medical, Inc. is recalling PENCAN and Spinocan spinal anesthesia convenience kits because they contain Bupivacaine Hydrochloride in Dextrose Injection manufactured by Huons Co., Ltd., which was recalled due to potential compromise. Risks include infection, inflammatory response, reduced anesthetic effectiveness, and meningitis. The FDA has classified this as a serious recall following reports of 35 serious injuries.
Win Woo Trading, LLC / HF Foods Group — Foreign Supplier Verification Program (FSVP)
Win Woo Trading, LLC / HF Foods Group
The FDA issued a Warning Letter to Win Woo Trading, LLC / HF Foods Group for failing to develop and implement a Foreign Supplier Verification Program (FSVP) for multiple imported food products, including gelatin, brown sugar, tapioca starch, and various teas.
International Medication Systems Limited — CGMP/Finished Pharmaceuticals/Adulterated
International Medication Systems Limited
The FDA issued a Warning Letter to International Medication Systems Limited for severe CGMP violations in manufacturing sterile injectable drugs. Inspections revealed insect larvae and gross microbial contamination in aseptic processing areas, extensive manual interventions defeating the purpose of restricted access barrier systems, and biofilm in the water storage system. The company voluntarily recalled lot EA038A5 of epinephrine injection and is required to submit a comprehensive remediation plan, utilizing a qualified third-party consultant.
Nihon Kohden Digital Health Solutions, LLC — Medical Device/Adulterated/Misbranded/Lacks PMA and/or 510(k)
Nihon Kohden Digital Health Solutions, LLC
The FDA issued a Warning Letter to Nihon Kohden Digital Health Solutions, LLC for marketing its Next Generation NetKonnect software device without required 510(k) clearance. The firm made significant modifications to the device's control mechanisms (adding a 'Silence Alarms' function) and intended use (claiming 'device-agnostic compatibility') which could impact safety and effectiveness. These unapproved changes render the device adulterated and misbranded under federal law. The firm has 15 business days to respond with corrective actions.
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Moisturizer line · Next audit: Q2 2026
“Does the new BHA guidance apply to our moisturizer line? I need to know before our next audit.”
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Q3 launch timeline · Collagen SKU at risk
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