21 CFR 803.18
Adverse events--all info not in file
- Inspections citing it: 55
- Of those classified, ended OAI: 20%
- Last cited: FY2025
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.
- 803.18(b)(1)(i)
- 18 · Adverse events--all info not in file
- 803.18(e)
- 15 · MDR not evaluated per 820.198
- 803.18(a)
- 13 · Event files -- failure to establish and maintain
- 803.18(d)(1)
- 9 · Distributor responsibilities for complaint records
Regulation Text
eCFR did not answer; open it on eCFRRecently Cited Sites
Newest inspections citing this section; each opens the site- Knox Medical Diagnostics, Inc.United States · Aug 21, 2024
- SpineCraft, LLC.United States · Mar 22, 2024
- Carolon CompanyUnited States · Jun 15, 2023
- Gauthier Biomedical, Inc.United States · Dec 21, 2021
- Colgate-Palmolive CompanyUnited States · Jul 15, 2021
- Philosys Co. LtdUnknown · Aug 30, 2018
- Avanos Medical, Inc.United States · Jul 29, 2016
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