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21 CFR 211.80

Procedures To Be in Writing

  • Inspections citing it: 658
  • Of those classified, ended OAI: 25%
  • 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.

211.80(a)
406 · Procedures To Be in Writing
211.80(b)
148 · Handling and Storage to Prevent Contamination
211.80(d)
95 · Status of Each Lot Identified
211.80(c)
9 · Storage off Floor, Spaced Suitably

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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