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21 CFR 812.5

Label does not contain required information

  • Inspections citing it: 5
  • Of those classified, ended OAI: 60%
  • Last cited: FY2025

Inspections Citing It by Fiscal Year

Sites in and outside the US, FY2017 to Oct 20, 2026.

Regulation Text

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Open 21 CFR 812.5 on eCFR

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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