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21 CFR Encyclopedia → 21 CFR 111.75(c)
21 CFR 111.75(c) Dietary Supplements 227 Annual Form 483 Citations

21 CFR 111.75(c) — Failure to verify finished dietary supplement batch meets product specifications

Plain-English Risk Theme: Finished Product Testing, Stability & Expiration Dating · Official eCFR Text ↗
🛡️ Test Your SOP Against 21 CFR 111.75(c) →
Official FDA Inspectional Observation Template
"Your firm failed to verify, for a subset of finished dietary supplement batches that you identify through a sound statistical sampling plan, or for every finished batch, that your finished batch of the dietary supplement meets product specifications for identity, purity, strength, and composition."
Plain-English Brand & QA Translation
Releasing finished batches without verifying strength/potency/microbiological specs, or placing an expiration/best-by date on labels without supporting real-time or accelerated stability data.
🚨 Why 15-Day Form 483 Responses Fail on 21 CFR 111.75(c):
FDA routinely rejects 15-day Form 483 responses for 21 CFR 111.75(c) 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(c).
  2. Systemic Root-Cause & SOP Overhaul (Days 4–10): Require finished-batch microbiological (USP <2021>/<2022>), heavy metal, and active-assay release testing plus ICH stability chamber protocols supporting every label shelf-life claim.
  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(c))

FREE AUDIT-READY BOILERPLATE 
STANDARD OPERATING PROCEDURE — COMPLIANCE CLAUSE 21 CFR 111.75(c)
1. PURPOSE: Establish mandatory cGMP controls satisfying 21 CFR 111.75(c) (Failure to verify finished dietary supplement batch meets product specifications).
2. REQUIREMENT: Require finished-batch microbiological (USP <2021>/<2022>), heavy metal, and active-assay release testing plus ICH stability chamber protocols supporting every label shelf-life claim.
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(c)

Thomas W. Halvorsen (Southeast Division (Florida District)) →Jonathan A. Vance (Southwest Division (Denver District)) →

Published Form 483s Citing 21 CFR 111.75(c)

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