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21 CFR 212.40

Use of reliable suppliers

  • Inspections citing it: 17
  • Of those classified, ended OAI: 19%
  • 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.

212.40(c)
7 · Use of reliable suppliers
212.40(a)
5 · Suitable for intended use
212.40(b)
5 · Written specifications - components

Regulation Text

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Open 21 CFR 212.40 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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