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21 CFR Encyclopedia → 21 CFR 111.260
21 CFR 111.260 Foods 103 Annual Form 483 Citations

21 CFR 111.260 — Batch record - required information

Plain-English Risk Theme: Master Manufacturing & Batch Production Records (MMR/BPR) · Official eCFR Text ↗
🛡️ Test Your SOP Against 21 CFR 111.260 →
Official FDA Inspectional Observation Template
"Your batch production record did not include all required information. Specifically, ***"
Plain-English Brand & QA Translation
Missing Master Manufacturing Records (MMRs) or incomplete Batch Production Records (BPRs) lacking exact component weights, lot numbers, yield reconciliation, or second-person verification.
🚨 Why 15-Day Form 483 Responses Fail on 21 CFR 111.260:
FDA routinely rejects 15-day Form 483 responses for 21 CFR 111.260 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 111.260.
  2. Systemic Root-Cause & SOP Overhaul (Days 4–10): Ensure every product SKU has an approved MMR matching the exact label claim and every batch record captures raw material lot traceability, in-process weight/pH checks, and QA release signatures.
  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 111.260)

FREE AUDIT-READY BOILERPLATE 
STANDARD OPERATING PROCEDURE — COMPLIANCE CLAUSE 21 CFR 111.260
1. PURPOSE: Establish mandatory cGMP controls satisfying 21 CFR 111.260 (Batch record - required information).
2. REQUIREMENT: Ensure every product SKU has an approved MMR matching the exact label claim and every batch record captures raw material lot traceability, in-process weight/pH checks, and QA release signatures.
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 111.260

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

Published Form 483s Citing 21 CFR 111.260

Indexed in FDA ORA Inspectional Observations dataset.