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21 CFR 820.100

Lack of or inadequate procedures

  • Inspections citing it: 6,052
  • 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.

820.100(a)
4,330 · Lack of or inadequate procedures
820.100(b)
1,371 · Documentation
820.100(a)(1)
95 · Analysis of data sources
820.100(a)(3)
79 · Identification of actions needed
820.100(a)(4)
77 · CAPA verification/validation of corrective/preventive action
820.100(a)(2)
61 · Investigation procedures
820.100(a)(5)
24 · Changes to correct/prevent quality problems
820.100(a)(7)
10 · Identifying relevant info for management review

Regulation Text

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Open 21 CFR 820.100 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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