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21 CFR Encyclopedia → 21 CFR 117.10
21 CFR 117.10 Foods 223 Annual Form 483 Citations

21 CFR 117.10 — Personnel

Plain-English Risk Theme: Personnel GMP Training, Gowning & Hygienic Practices · Official eCFR Text ↗
🛡️ Test Your SOP Against 21 CFR 117.10 →
Official FDA Inspectional Observation Template
"You did not take a reasonable measure or precaution related to personnel practices. Specifically, ***"
Plain-English Brand & QA Translation
Operators performing manufacturing or QA tasks without documented GMP/SOP training, or observed gowning/hygiene deviations in production rooms.
🚨 Why 15-Day Form 483 Responses Fail on 21 CFR 117.10:
FDA routinely rejects 15-day Form 483 responses for 21 CFR 117.10 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 117.10.
  2. Systemic Root-Cause & SOP Overhaul (Days 4–10): Maintain role-based SOP training matrices signed prior to independent floor assignment and annual cGMP refresher assessments.
  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 117.10)

FREE AUDIT-READY BOILERPLATE 
STANDARD OPERATING PROCEDURE — COMPLIANCE CLAUSE 21 CFR 117.10
1. PURPOSE: Establish mandatory cGMP controls satisfying 21 CFR 117.10 (Personnel).
2. REQUIREMENT: Maintain role-based SOP training matrices signed prior to independent floor assignment and annual cGMP refresher assessments.
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 117.10

Rebecca M. Okafor (Pacific Northwest Division (Seattle District)) →

Published Form 483s Citing 21 CFR 117.10

Indexed in FDA ORA Inspectional Observations dataset.