21 CFR 812.25
Sponsor's lack of written monitoring procedures
- Inspections citing it: 19
- Of those classified, ended OAI: 42%
- Last cited: FY2025
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- Happy Health IncUnited States · May 29, 2025
- Kennedy, Philip R.United States · Oct 16, 2019
- Christopher J. Hartnick, MDUnited States · Jun 28, 2019
- CAO Group, Inc.United States · May 7, 2018
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