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21 CFR 812.150

Investigator report of unanticipated adverse effects

  • Inspections citing it: 89
  • 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.

812.150(a)(1)
29 · Investigator report of unanticipated adverse effects
812.150(b)(5)
22 · Sponsor progress reports for significant risk study
812.150(a)(4)
14 · Investigator non-emergency safety or soundness changes
812.150(a)(3)
12 · No investigator progress reports
812.150(b)(1)
7 · Sponsor evaluation rpt not timely, distributed
812.150(b)(2)
5 · Sponsor notification of IRB approval withdrawal

Regulation Text

eCFR did not answer; open it on eCFR

Open 21 CFR 812.150 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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