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21 CFR 211.180

Items to cover on annual reviews

  • Inspections citing it: 1,049
  • 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.

211.180(e)(2)
436 · Items to cover on annual reviews
211.180(e)(1)
284 · Review of representative number of batches
211.180(e)
210 · Records reviewed annually
211.180(c)
59 · Records not made readily available to FDA
211.180(b)
48 · Record maintenance 1 year (except exempt OTC)
211.180(f)
12 · Responsible firm officials notified in writing

Regulation Text

eCFR did not answer; open it on eCFR

Open 21 CFR 211.180 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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