21 CFR 820.160
Lack of or inadequate procedures for distribution
- Inspections citing it: 130
- 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.
Paragraphs Cited
As FDA posts them, all years.
- 820.160(a)
- 94 · Lack of or inadequate procedures for distribution
- 820.160(b)
- 36 · Distribution records
Regulation Text
eCFR did not answer; open it on eCFRRecently Cited Sites
Newest inspections citing this section; each opens the site- RG Medical USAUnited States · Oct 27, 2025
- Truemed Group LLCUnited States · Apr 28, 2025
- World Merchant Inc.United States · Apr 16, 2025
- Philips Ultrasound, IncUnited States · Mar 13, 2025
- Variamed, LLCUnited States · Dec 18, 2024
- Spintech LLCUnited States · Jun 8, 2022
- Dentonics, IncUnited States · Apr 28, 2022
- Allied Vision Group IncUnited States · Apr 22, 2022
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