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21 CFR Encyclopedia → 21 CFR 111.75(a)(2)(ii)
21 CFR 111.75(a)(2)(ii) Dietary Supplements 284 Annual Form 483 Citations

21 CFR 111.75(a)(2)(ii) — Reliance on supplier Certificate of Analysis (COA) without qualifying the supplier

Plain-English Risk Theme: Incoming Ingredient Identity Testing & COA Qualification · Official eCFR Text ↗
🛡️ Test Your SOP Against 21 CFR 111.75(a)(2)(ii) →
Official FDA Inspectional Observation Template
"Your firm relied on a certificate of analysis from a component supplier to confirm the identity of components without first establishing the reliability of the supplier's certificate of analysis through confirmation of the results of the supplier's tests or examinations."
Plain-English Brand & QA Translation
Failure to perform at least one test to verify the identity of every incoming dietary ingredient or raw component before use, or relying on a supplier's Certificate of Analysis (COA) without first qualifying the supplier.
🚨 Why 15-Day Form 483 Responses Fail on 21 CFR 111.75(a)(2)(ii):
FDA routinely rejects 15-day Form 483 responses for 21 CFR 111.75(a)(2)(ii) when a facility merely states 'we revised our SOP and retrained personnel' without attaching: (1) the signed, effective-dated SOP, (2) photographic or batch-log proof of implementation, and (3) a retrospective impact assessment of all commercial lots manufactured over the prior 24 months within expiry.
✅ Standard 15-Day CAPA Remediation Blueprint:
  1. Immediate Containment (Days 1–3): Place affected raw materials or in-process lots on QA Hold and open formal CAPA under 21 CFR 111.75(a)(2)(ii).
  2. Systemic Root-Cause & SOP Overhaul (Days 4–10): Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
  3. Retrospective Lot Review & Effectiveness Check (Days 11–15): Test retention samples of distributed lots and schedule a 30/60/90-day QA audit to prove sustained compliance.

Copy-Paste Compliant SOP Clause Template (21 CFR 111.75(a)(2)(ii))

FREE AUDIT-READY BOILERPLATE 
STANDARD OPERATING PROCEDURE — COMPLIANCE CLAUSE 21 CFR 111.75(a)(2)(ii)
1. PURPOSE: Establish mandatory cGMP controls satisfying 21 CFR 111.75(a)(2)(ii) (Reliance on supplier Certificate of Analysis (COA) without qualifying the supplier).
2. REQUIREMENT: Establish SOP-QA-004 requiring FTIR/HPLC/organoleptic identity testing on 100% of incoming dietary ingredient lots and annual audit + 3-lot confirmatory testing before relying on any vendor COA.
3. QA VERIFICATION & SIGN-OFF: Dual independent verification by Production and Quality Assurance Unit (QAU) is required prior to batch release. Any deviation or Out-of-Specification (OOS) result triggers a formal CAPA investigation within 24 hours.

FDA Investigators Who Frequently Cite 21 CFR 111.75(a)(2)(ii)

Elena R. Rostova (Pacific Southwest Division (Los Angeles District)) →

Published Form 483s Citing 21 CFR 111.75(a)(2)(ii)

Dxn Pharmaceutical Sdn Bhd Issued 2026-03-06
Read 483 Breakdown →