USFDA PHARMACEUTICAL
INSPECTION READINESS GUIDE
Do's & Don'ts — Verified FDA Regulatory Language
FDA does not inspect your facility — they inspect your systems, your data, and your culture.
Critical → Major → Minor → IBP (Industry Best Practice)
IOM 2025 (Feb 2026) · 21 CFR 210/211/Part 11 · FDA Data Integrity Guidance Dec 2018 · FDA 483 Response Guidance Mar 2026
Regulatory Reference
Regulatory Sources
- IOM 2025 Chapter 5 (fda.gov,updated Feb 17,2026)
- 21 CFR 210/211/Part 11
Supporting Guidance
- FDA Data Integrity Q & A (Dec 2018)
- FDA Draft Guidance on 483 Responses (Mar 9, 2026, Docket FDA-2025-D-1504)
Statutory Authority
- FD&C Act §704(a) (Inspection Authority)
- §301(f) (Prohibited Acts)
- 18 U.S.C. §1519
FDA Terminology — What the FDA Actually Says
Many pharmaceutical inspection consulting guides use terms that do not appear anywhere in FDA regulatory documents. This guide uses only the FDA's own words. The table below shows the corrections.
| Common Term | FDA Official Term | FDA Source |
|---|---|---|
| Escort | Firm's Representative | IOM 2025, §5.5.9.3 |
| Scribe | Not in FDA Documents — IBP Only | No FDA source |
| Front Room | Firm Management / Quality Unit Representatives | IOM 2025, §5.5.12; 21 CFR 211.22 |
| Back Room / War Room | Quality Control Unit | 21 CFR 211.22(a) |
| Closing Conference | Closing Meeting | IOM 2025, §5.5.12.2 |
| SME (Subject Matter Expert) | Qualified Person /Personnel Per 21 CFR 211.25 | 21 CFR 211.25 |
Severity Classification Legend
Directly grounded in an explicit regulatory requirement. Failure constitutes a CGMP violation observable on Form FDA 483. May contribute to OAI classification.
Based on a regulatory requirement, it commonly generates a Form FDA 483 observation. May contribute to VAI or OAI classification.
Based on a regulatory requirement, it represents a less severe documentation or procedural gap. May generate an informal comment or softer observation.
Industry Best Practice — professional consensus that is NOT found in FDA regulatory documents. Explicitly labeled so readers can distinguish it from regulatory requirements.