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21 CFR Encyclopedia → 21 CFR 211.160(b)
21 CFR 211.160(b) Drugs 121 Annual Form 483 Citations

21 CFR 211.160(b) — Scientifically sound laboratory controls

Plain-English Risk Theme: Incoming Ingredient Identity Testing & COA Qualification · Official eCFR Text ↗
🛡️ Test Your SOP Against 21 CFR 211.160(b) →
Official FDA Inspectional Observation Template
"Laboratory controls do not include the establishment of scientifically sound and appropriate [specifications] [standards] [sampling plans] [test procedures] designed to assure that [components] [drug product containers] [closures] [in-process materials] [labeling] [drug products] conform to appropriate standards of identity, strength, quality and purity. 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 211.160(b):
FDA routinely rejects 15-day Form 483 responses for 21 CFR 211.160(b) 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 211.160(b).
  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 211.160(b))

FREE AUDIT-READY BOILERPLATE 
STANDARD OPERATING PROCEDURE — COMPLIANCE CLAUSE 21 CFR 211.160(b)
1. PURPOSE: Establish mandatory cGMP controls satisfying 21 CFR 211.160(b) (Scientifically sound laboratory controls).
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 211.160(b)

David K. Chen (Northeast Division (New Jersey District)) →

Published Form 483s Citing 21 CFR 211.160(b)

Read 483 Breakdown →
RC Outsourcing LLC Issued 2026-09-03
Read 483 Breakdown →