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21 CFR 820.80

Lack of or inadequate final acceptance procedures

  • Inspections citing it: 2,524
  • Of those classified, ended OAI: 24%
  • 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.

820.80(d)
669 · Lack of or inadequate final acceptance procedures
820.80(b)
660 · Lack of or inadequate receiving acceptance procedures
820.80(a)
559 · Lack of or inadequate procedures - Acceptance activities
820.80(e)
352 · Documentation
820.80(c)
261 · Lack of or inadequate In-process acceptance procedures
820.80(d)(3)
9 · No release signature
820.80(d)(1)
7 · DMR required activities {see also 820.181}
820.80(d)(2)
7 · Review of data and documentation

Regulation Text

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Recently Cited Sites

Newest inspections citing this section; each opens the site

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

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