21 CFR 806.20
Justification for not reporting
- Inspections citing it: 189
- 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.
- 806.20(b)(4)
- 119 · Justification for not reporting
- 806.20(a)
- 52 · Records not kept
- 806.20(b)(3)
- 9 · Events
- 806.20(b)(5)
- 9 · Records of communications
Regulation Text
eCFR did not answer; open it on eCFRRecently Cited Sites
Newest inspections citing this section; each opens the site- Lynn Medical Instrument Co.United States · Jul 31, 2026
- Rockwell Medical, IncUnited States · Nov 20, 2025
- ARCHEONFrance · Sep 19, 2025
- RENISHAW MAYFIELDFrance · Jun 12, 2025
- Prentke Romich CompanyUnited States · May 1, 2025
- Five Star Orthodontic Laboratory & Supply, Inc.United States · Mar 17, 2025
- Immucor, Inc.United States · Feb 20, 2025
- NeuroSync, Inc.United States · Feb 5, 2025
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