21 CFR 820.35
Records for complaints involving failure to meet specifications not maintained
- Inspections citing it: 14
- Of those classified, ended OAI: 29%
- Last cited: FY2027
Inspections Citing It by Fiscal Year
Sites in and outside the US, FY2018 to Oct 20, 2026.
Paragraphs Cited
As FDA posts them, all years.
- 820.35(a)
- 9 · Records for complaints involving failure to meet specifications not maintained
- 820.35(c)
- 5 · UDI was not recorded for each medical device or batch
Regulation Text
eCFR did not answer; open it on eCFRCounts 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