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21 CFR Encyclopedia → 21 CFR 820.50
21 CFR 820.50 Devices 115 Annual Form 483 Citations

21 CFR 820.50 — Purchasing controls, Lack of or inadequate procedures

Plain-English Risk Theme: Supplier Qualification & Foreign Supplier Verification (FSVP) · Official eCFR Text ↗
🛡️ Test Your SOP Against 21 CFR 820.50 →
Official FDA Inspectional Observation Template
"Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements have not been [adequately] established. Specifically, ***"
Plain-English Brand & QA Translation
Failure to develop or maintain a Foreign Supplier Verification Program (FSVP) or approved vendor qualification file verifying that raw material suppliers meet U.S. FDA safety standards.
🚨 Why 15-Day Form 483 Responses Fail on 21 CFR 820.50:
FDA routinely rejects 15-day Form 483 responses for 21 CFR 820.50 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 820.50.
  2. Systemic Root-Cause & SOP Overhaul (Days 4–10): Maintain an Approved Supplier List (ASL) with hazard analysis, third-party GMP audit certificates, and FSVP importer identification for every foreign ingredient.
  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 820.50)

FREE AUDIT-READY BOILERPLATE 
STANDARD OPERATING PROCEDURE — COMPLIANCE CLAUSE 21 CFR 820.50
1. PURPOSE: Establish mandatory cGMP controls satisfying 21 CFR 820.50 (Purchasing controls, Lack of or inadequate procedures).
2. REQUIREMENT: Maintain an Approved Supplier List (ASL) with hazard analysis, third-party GMP audit certificates, and FSVP importer identification for every foreign ingredient.
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 820.50

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

Published Form 483s Citing 21 CFR 820.50

Indexed in FDA ORA Inspectional Observations dataset.