Start with where FDA actually finds problems
The best guide to an FDA drug GMP inspection is what investigators wrote last year. In FY2025, Form 483 observations under 21 CFR Part 211 totalled 2,837 citations across 316 provisions (GMP Insiders). The top ten:
| Rank | CFR | Topic | Citations |
|---|---|---|---|
| 1 | 211.22(d) | Quality unit procedures missing or not followed | 243 |
| 2 | 211.192 | Inadequate investigation of discrepancies and failures | 164 |
| 3 | 211.100(a) | Missing or inadequate written production procedures | 162 |
| 4 | 211.160(b) | Laboratory controls not scientifically sound | 121 |
| 5 | 211.67(a) | Cleaning, sanitizing and maintenance | 95 |
| 6 | 211.68(b) | Computerized system and master record controls | 87 |
| 7 | 211.63 | Equipment design, size or location | 81 |
| 8 | 211.67(b) | Cleaning procedures not established or followed | 70 |
| 9 | 211.113(b) | Sterile product contamination control | 68 |
| 10 | 211.165(a) | Testing and release for distribution | 44 |
For a QA manager, the first three are the core of the job: the quality unit’s own procedures, investigations, and written procedures.
Area 1: The quality unit’s own house (211.22)
21 CFR 211.22 requires a quality control unit with responsibility and authority to approve or reject components, products and procedures, and requires its responsibilities and procedures to be in writing and followed (21 CFR 211.22). Paragraph (d), the most-cited provision of FY2025, is about exactly that: written procedures for the quality unit, followed in practice.
Readiness questions:
- Is every quality unit responsibility covered by a procedure?
- Do records show the procedure was followed, every time?
- Does the quality unit actually exercise its authority (rejections, holds, escalations)?
Area 2: Investigations (211.192)
Under 21 CFR 211.192, the quality control unit must review and approve production and control records before release, and any unexplained discrepancy or batch failure must be thoroughly investigated, whether or not the batch has been distributed. The investigation must extend to other batches and products that may be affected, and a written record must include conclusions and follow-up (21 CFR 211.192).
Review a sample of recent deviations and ask:
- Is the root cause supported by evidence, or is it “human error” by default?
- Was impact on other batches and products assessed?
- Is the CAPA linked and effective?
Area 3: Written procedures (211.100)
21 CFR 211.100 requires written procedures for production and process control, reviewed and approved by the quality control unit, followed and documented when performed; any deviation must be recorded and justified (21 CFR 211.100).
The usual gaps are procedures that do not match practice, and deviations handled informally on the floor.
Area 4: The rest of the top ten
Laboratory controls, cleaning, computerized systems and equipment make up most of the remaining citations. Assign owners for each and run a short self-inspection against the relevant sections. Laboratory controls deserve special attention (see the companion article for QC managers).
A 30-day readiness plan
| Week | Focus |
|---|---|
| 1 | Self-inspection against the top ten provisions; list gaps |
| 2 | Deviation and investigation sample review; fix open items |
| 3 | Procedure-versus-practice walkthroughs on the floor and in the lab |
| 4 | Front-room and back-room rehearsal; document retrieval drill |
Beyond compliance: quality management maturity
FDA’s voluntary Quality Management Maturity (QMM) prototype assessment program entered its third year in 2026, with nine drug establishments to be assessed on how effectively they monitor and manage quality (Arnold & Porter). Even if your site does not take part, it signals where FDA’s thinking is heading: from “is there a procedure?” to “does the system work?”
Who you work with
- Production and plant management: procedures and deviations.
- QC laboratory: lab controls and OOS investigations.
- Engineering and maintenance: cleaning, equipment and computerized systems.
- Regulatory affairs: commitments in applications and pre-approval inspections.
- Site leadership: resources and the inspection host role.
Common weaknesses
- Quality unit procedures that describe intentions rather than what QA does.
- Investigations closed with unsupported root causes.
- Procedures not updated after process changes.
- Self-inspections that check paperwork but never walk the floor.
- Slow document retrieval during inspection.
Checklist
- Self-inspection against FY2025 top ten complete
- Quality unit responsibilities fully proceduralized
- Ten recent investigations reviewed for root cause and impact
- Procedure-versus-practice walkthroughs done
- Retrieval drill passed
- Front-room team rehearsed
How AskDona helps
Inspection readiness means reading procedures, deviations and batch records against Part 211 and your own commitments. AskDona reads those documents against the requirements you choose and flags gaps, such as an investigation without impact assessment or a procedure missing a required element, with page citations. Run a sample inspection-readiness review on ten recent deviations. AskDona shows the evidence; your QA team decides.
Editor’s note: FY2025 counts come from GMP Insiders’ analysis of FDA’s published 483 data, which does not represent every inspection. CFR summaries are paraphrased. Not legal advice. The LinkedIn count was supplied by the client.
FAQ
What was the most-cited drug GMP observation in FY2025? 21 CFR 211.22(d), quality unit procedures, with 243 citations.
What does 211.192 require? QC unit review of production records and thorough, documented investigation of discrepancies and failures.
How long does inspection readiness take? A focused effort can be organized in about four weeks, but readiness should be continuous.
What is FDA’s QMM program? A voluntary CDER program assessing how well manufacturers monitor and manage quality; 2026 is its third year.
References
All pages opened and checked by October 23, 2026.
| Source | Type | Used for |
|---|---|---|
| GMP Insiders: FY2025 FDA inspection observations | Industry analysis | Top ten citations |
| 21 CFR 211.22 (LII) | Regulation | Quality unit |
| 21 CFR 211.192 (LII) | Regulation | Record review and investigations |
| 21 CFR 211.100 (LII) | Regulation | Written procedures |
| Arnold & Porter: FDA QMM third year | Law firm advisory | QMM program |