21 CFR 820.170
Lack of or inadequate instructions
- Inspections citing it: 58
- Of those classified, ended OAI: 19%
- 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.
- 820.170(a)
- 37 · Lack of or inadequate instructions
- 820.170(b)
- 21 · Installer records
Regulation Text
eCFR did not answer; open it on eCFRRecently Cited Sites
Newest inspections citing this section; each opens the site- NeuroCareAI, Inc.United States · Dec 12, 2025
- Exer Labs, Inc.United States · Oct 24, 2024
- Healthy Spirit, LLCUnited States · Nov 3, 2023
- REACT Innovations, LLCUnited States · Feb 17, 2023
- Siemens Medical Solutions USA, IncUnited States · Oct 26, 2022
- Compumedics USA, IncUnited States · Sep 16, 2021
- Algomedica, Inc.United States · Aug 22, 2019
- Excel Medical Electronics LLCUnited States · Mar 13, 2019
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