21 CFR Encyclopedia → 21 CFR 117.130(a)(1)
21 CFR 117.130(a)(1)
Foods
194 Annual Form 483 Citations
21 CFR 117.130(a)(1) — Hazard analysis - Identification of hazard
Plain-English Risk Theme: Electronic Record Data Integrity (21 CFR Part 11) & Retention · Official eCFR Text ↗
Official FDA Inspectional Observation Template
"Your hazard analysis did not identify a hazard that required a preventive control. Specifically, ***"
Plain-English Brand & QA Translation
Uncontrolled spreadsheets, shared laboratory logins, missing audit trails, backdated entries, or failure to retain batch and distribution records for the statutory window.
🚨 Why 15-Day Form 483 Responses Fail on 21 CFR 117.130(a)(1):
FDA routinely rejects 15-day Form 483 responses for 21 CFR 117.130(a)(1) 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 117.130(a)(1).
- Systemic Root-Cause & SOP Overhaul (Days 4–10): Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention.
- 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 117.130(a)(1))
FREE AUDIT-READY BOILERPLATESTANDARD OPERATING PROCEDURE — COMPLIANCE CLAUSE 21 CFR 117.130(a)(1) 1. PURPOSE: Establish mandatory cGMP controls satisfying 21 CFR 117.130(a)(1) (Hazard analysis - Identification of hazard). 2. REQUIREMENT: Enforce unique user credentials, immutable audit trails on analytical instruments, controlled form issuance numbers, and 2-year post-expiration record retention. 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 117.130(a)(1)
Published Form 483s Citing 21 CFR 117.130(a)(1)
Indexed in FDA ORA Inspectional Observations dataset.