21 CFR Encyclopedia → 21 CFR 211.22(d)
21 CFR 211.22(d)
Drugs
243 Annual Form 483 Citations
21 CFR 211.22(d) — Procedures not in writing, fully followed
Plain-English Risk Theme: Electronic Record Data Integrity (21 CFR Part 11) & Retention · Official eCFR Text ↗
Official FDA Inspectional Observation Template
"The responsibilities and procedures applicable to the quality control unit are not [in writing] [fully followed]. 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 211.22(d):
FDA routinely rejects 15-day Form 483 responses for 21 CFR 211.22(d) 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 211.22(d).
- 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 211.22(d))
FREE AUDIT-READY BOILERPLATESTANDARD OPERATING PROCEDURE — COMPLIANCE CLAUSE 21 CFR 211.22(d) 1. PURPOSE: Establish mandatory cGMP controls satisfying 21 CFR 211.22(d) (Procedures not in writing, fully followed). 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 211.22(d)
Published Form 483s Citing 21 CFR 211.22(d)
Victory Medical Center Pharmacy
Issued 2026-09-10
Read 483 Breakdown →