21 CFR 211.25
Training--operations, GMPs, written procedures
- Inspections citing it: 1,535
- Of those classified, ended OAI: 25%
- Last cited: FY2026
Inspections Citing It by Fiscal Year
Sites in and outside the US, FY2017 to Oct 20, 2026.
Paragraphs Cited
As FDA posts them, all years.
- 211.25(a)
- 1,372 · Training--operations, GMPs, written procedures
- 211.25(b)
- 84 · Supervisor Training/Education/Experience
- 211.25(c)
- 79 · Inadequate number of personnel
Regulation Text
eCFR did not answer; open it on eCFRRecently Cited Sites
Newest inspections citing this section; each opens the site- Neilmed Pharmaceuticals IncUnited States · Jul 22, 2026
- Boiron Inc.United States · Jun 26, 2026
- Biokosmes SrlItaly · Jun 26, 2026
- Scinopharm Taiwan, Ltd.Taiwan · Jun 23, 2026
- Epien Medical, IncUnited States · Aug 28, 2025
- Fagron Compounding ServicesUnited States · Aug 8, 2025
- LGM Pharma Solutions, LLC.United States · Aug 6, 2025
- Nielsen Biosciences, IncUnited States · Apr 17, 2025
- Laboratoires DelonCanada · Feb 21, 2025
- Oasis Medical, Inc.United States · Jan 27, 2025
- SOHM, Inc.United States · Nov 5, 2024
- LCC Ltd.Unknown · Mar 22, 2024
Counts are inspections with posted citations that cite any paragraph of the section, once per inspection, from FDA's Data Dashboard. OAI share is over inspections FDA finally classified. Text from eCFR, the official online CFR. FDA Data Dashboard and eCFR