21 CFR Encyclopedia → 21 CFR 111.70(e)
21 CFR 111.70(e)
Foods
188 Annual Form 483 Citations
21 CFR 111.70(e) — Specifications - finished dietary supplement
Plain-English Risk Theme: Incoming Ingredient Identity Testing & COA Qualification · Official eCFR Text ↗
Official FDA Inspectional Observation Template
"You did not establish product specifications for [identity] [purity] [strength] [composition] [limits on contamination]. Specifically, ***"
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 111.70(e):
FDA routinely rejects 15-day Form 483 responses for 21 CFR 111.70(e) 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:
- Immediate Containment (Days 1–3): Place affected raw materials or in-process lots on QA Hold and open formal CAPA under 21 CFR 111.70(e).
- 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.
- 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 111.70(e))
FREE AUDIT-READY BOILERPLATESTANDARD OPERATING PROCEDURE — COMPLIANCE CLAUSE 21 CFR 111.70(e) 1. PURPOSE: Establish mandatory cGMP controls satisfying 21 CFR 111.70(e) (Specifications - finished dietary supplement). 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 111.70(e)
Published Form 483s Citing 21 CFR 111.70(e)
Indexed in FDA ORA Inspectional Observations dataset.