What FDA Investigators Cited Most at Drug Sites in FY2026
FDA publishes the individual citations behind many inspection outcomes on its Data Dashboard. RegDataLab loads them into one searchable table, so you can count what investigators wrote up without stitching spreadsheets together. Here is what the fiscal 2026 drug citations show.
Scope. Counts come from RegDataLab’s copy of the FDA Data Dashboard inspection citations, queried on October 13, 2026, for program area “Drugs” and FDA fiscal year 2026 (October 1, 2025 to September 30, 2026), covering inspections through August 2026. A count is citations, not inspections: one inspection can cite the same section more than once.
The headline numbers
- 1,321 published drug citations from FY2026 inspections so far.
- 567 of them (43%) come from inspections classified OAI (Official Action Indicated), which means regulatory and/or administrative actions are recommended.
- For comparison, FY2025 has 2,526 published drug citations across the full year.
Citations by 21 CFR 211 section
We counted the sections that most often appear in drug CGMP findings. Each row matches the section and its paragraphs (211.22 includes 211.22(a) through 211.22(d)).
| Section | What it covers | FY2026 citations |
|---|---|---|
| 211.22 | Responsibilities of the quality control unit | 137 |
| 211.192 | Production record review and investigation of discrepancies | 122 |
| 211.67 | Equipment cleaning and maintenance | 106 |
| 211.160 | Laboratory controls | 105 |
| 211.100 | Written production and process control procedures | 84 |
| 211.68 | Automatic, mechanical and electronic equipment (including computer controls) | 71 |
| 211.113 | Control of microbiological contamination | 68 |
| 211.84 | Testing and approval of components, containers and closures | 68 |
| 211.42 | Design and construction features | 65 |
| 211.166 | Stability testing | 45 |
| 211.194 | Laboratory records | 36 |
| 211.165 | Testing and release for distribution | 34 |
| 211.110 | Sampling and testing of in-process materials | 25 |
| 211.188 | Batch production and control records | 24 |
| 211.25 | Personnel qualifications and training | 23 |
What stands out
The quality unit and investigations lead. 211.22 and 211.192 together account for 259 citations, about one in five of the total. Both are about whether the firm’s own quality system catches and closes problems, rather than about a single piece of equipment or test.
Cleaning and the lab are close behind. Equipment cleaning (211.67) and laboratory controls (211.160) each passed 100 citations. If you audit suppliers, these are the procedures and records most worth asking to see.
Computer controls are a steady theme. 211.68 has 71 citations. Its paragraph (b) covers who can change master records and whether data is backed up, which is where most data integrity findings land in the Dashboard’s coding.
Run the same count yourself
Every number above is one call to fda_citations. The response includes a
total_count, so a limit of 1 is enough for counting:
fda_citations({
"fiscal_year": 2026,
"program_area": "Drugs",
"act_cfr_number": "211.192",
"limit": 1
})Narrow it to OAI inspections, a keyword or one supplier’s site:
fda_citations({ "fiscal_year": 2026, "program_area": "Drugs", "classification": "OAI", "limit": 1 })
fda_citations({ "fiscal_year": 2026, "keyword": "cleaning validation" })
fda_citations({ "fei_number": "3008294355" })
Each citation row carries the FEI number, inspection ID, end date, classification and a link to
the firm’s FDA Data Dashboard profile, so you can go from a count to the underlying
inspection with fda_inspections, or to a company-level view with
fda_manufacturing_risk_summary.
Or ask in plain language once RegDataLab is connected to Claude, Cursor or ChatGPT: “Which 21 CFR 211 sections were cited most at drug sites in FY2026, and how many of those citations came from OAI inspections?”
Reading citations carefully
- A citation is an investigator’s observation. It is not FDA’s final determination that a violation occurred.
- Not every inspection has published citations, and publication lags the inspection by weeks to months.