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21 CFR 820.75

Lack of or inadequate process validation

  • Inspections citing it: 2,407
  • Of those classified, ended OAI: 25%
  • 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.

820.75(a)
1,850 · Lack of or inadequate process validation
820.75(b)
265 · Lack/Inad procedure-Monitoring/Control of Validated Proces
820.75(c)
203 · Process changes - review, evaluation and revalidation
820.75(b)(2)
89 · Documentation of validated process performance

Regulation Text

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Open 21 CFR 820.75 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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