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21 CFR 211.165

Testing and release for distribution

  • Inspections citing it: 1,899
  • Of those classified, ended OAI: 40%
  • 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.

211.165(a)
850 · Testing and release for distribution
211.165(e)
401 · Test methods
211.165(b)
264 · Microbiological testing
211.165(f)
176 · Failing drug products not rejected
211.165(d)
119 · Acceptance criteria for sampling & testing
211.165(c)
89 · Sampling and testing plans not described

Regulation Text

eCFR did not answer; open it on eCFR

Open 21 CFR 211.165 on eCFR

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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