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21 CFR Encyclopedia → 21 CFR 117.80(c)
21 CFR 117.80(c) Foods 200 Annual Form 483 Citations

21 CFR 117.80(c) — Manufacturing, processing, packing, holding - Controls

Plain-English Risk Theme: Label Control, Undeclared Allergens & Structure/Function Claims · Official eCFR Text ↗
🛡️ Test Your SOP Against 21 CFR 117.80(c) →
Official FDA Inspectional Observation Template
"You did not conduct operations under conditions and controls necessary to minimize the potential for [growth or survival of microorganisms] [allergen cross-contact] [contamination of food] [deterioration of food]. Specifically, ***"
Plain-English Brand & QA Translation
Undeclared major food allergens (milk, soy, wheat, tree nuts, peanuts, egg, sesame), label mix-ups at the packaging line, or unauthorized disease treatment claims.
🚨 Why 15-Day Form 483 Responses Fail on 21 CFR 117.80(c):
FDA routinely rejects 15-day Form 483 responses for 21 CFR 117.80(c) 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 117.80(c).
  2. Systemic Root-Cause & SOP Overhaul (Days 4–10): Implement 100% barcode/vision verification on packaging lines, strict allergen matrix segregation, and regulatory review removing disease endpoints from supplement/cosmetic copy.
  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 117.80(c))

FREE AUDIT-READY BOILERPLATE 
STANDARD OPERATING PROCEDURE — COMPLIANCE CLAUSE 21 CFR 117.80(c)
1. PURPOSE: Establish mandatory cGMP controls satisfying 21 CFR 117.80(c) (Manufacturing, processing, packing, holding - Controls).
2. REQUIREMENT: Implement 100% barcode/vision verification on packaging lines, strict allergen matrix segregation, and regulatory review removing disease endpoints from supplement/cosmetic copy.
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 117.80(c)

Marcus V. Delgado (Southwest Division (Dallas District)) →Elena R. Rostova (Pacific Southwest Division (Los Angeles District)) →David K. Chen (Northeast Division (New Jersey District)) →

Published Form 483s Citing 21 CFR 117.80(c)

Indexed in FDA ORA Inspectional Observations dataset.