21 CFR 211.192
Investigations of discrepancies, failures
- Inspections citing it: 2,552
- Of those classified, ended OAI: 29%
- Last cited: FY2026
Inspections Citing It by Fiscal Year
Sites in and outside the US, FY2017 to Oct 20, 2026.
Regulation Text
eCFR did not answer; open it on eCFRRecently Cited Sites
Newest inspections citing this section; each opens the site- Baxter Healthcare CorporationUnited States · Sep 23, 2026
- ACTA Laboratories, Inc.United States · Sep 4, 2026
- Microbac Laboratories, Inc.United States · Sep 3, 2026
- Steril-Gene Life Sciences Private LtdIndia · Aug 12, 2026
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