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21 CFR 820.30

Design Validation - Risk analysis not performed/inadequate

  • Inspections citing it: 5,714
  • Of those classified, ended OAI: 26%
  • 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.

820.30(g)
1,689 · Design Validation - Risk analysis not performed/inadequate
820.30(i)
1,000 · Design changes - Lack of or Inadequate Procedures
820.30(a)
679 · Design control - no procedures
820.30(f)
629 · Design verification - Lack of or inadequate procedures
820.30(j)
471 · Design history file
820.30(e)
341 · Design review - Lack of or inadequate procedures
820.30(c)
334 · Design input - documentation
820.30(h)
228 · Design transfer - Lack of or inadequate procedures

Regulation Text

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Open 21 CFR 820.30 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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