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21 CFR Encyclopedia → 21 CFR 117.135(c)(3)
21 CFR 117.135(c)(3) Foods 86 Annual Form 483 Citations

21 CFR 117.135(c)(3) — Sanitation preventive controls - Appropriate (Adequate)

Plain-English Risk Theme: Cleaning Validation, Sanitation Logs & Pest Control · Official eCFR Text ↗
🛡️ Test Your SOP Against 21 CFR 117.135(c)(3) →
Official FDA Inspectional Observation Template
"Your written sanitation [preventive control] [monitoring] [corrective action] [verification] procedures were not appropriate to significantly minimize or prevent the hazard requiring a preventive control. Specifically, ***"
Plain-English Brand & QA Translation
Incomplete equipment cleaning/sanitation logs, inadequate allergen or cross-contamination changeover validation, or gaps in facility pest exclusion.
🚨 Why 15-Day Form 483 Responses Fail on 21 CFR 117.135(c)(3):
FDA routinely rejects 15-day Form 483 responses for 21 CFR 117.135(c)(3) 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 117.135(c)(3).
  2. Systemic Root-Cause & SOP Overhaul (Days 4–10): Implement lot-linked equipment cleaning verification logs with QA sign-off before line clearance, ATP/allergen swabbing after shared-line runs, and weekly documented pest-control inspections.
  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 117.135(c)(3))

FREE AUDIT-READY BOILERPLATE 
STANDARD OPERATING PROCEDURE — COMPLIANCE CLAUSE 21 CFR 117.135(c)(3)
1. PURPOSE: Establish mandatory cGMP controls satisfying 21 CFR 117.135(c)(3) (Sanitation preventive controls - Appropriate (Adequate)).
2. REQUIREMENT: Implement lot-linked equipment cleaning verification logs with QA sign-off before line clearance, ATP/allergen swabbing after shared-line runs, and weekly documented pest-control inspections.
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 117.135(c)(3)

Sarah J. Lindqvist (Central Division (Chicago District)) →

Published Form 483s Citing 21 CFR 117.135(c)(3)

Indexed in FDA ORA Inspectional Observations dataset.