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21 CFR 640.63

Determining donor suitability

  • Inspections citing it: 15
  • Of those classified, ended OAI: 20%

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.

640.63(a)
10 · Determining donor suitability
640.63(d)
5 · Unreliable answers

Regulation Text

eCFR did not answer; open it on eCFR

Open 21 CFR 640.63 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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