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21 CFR 820.184

Lack of or inadequate DHR procedures

  • Inspections citing it: 1,888
  • Of those classified, ended OAI: 20%
  • 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.

820.184
1,751 · Lack of or inadequate DHR procedures
820.184(f)
51 · DHR - UDI not included
820.184(d)
47 · Acceptance records
820.184(e)
31 · ID label, labeling
820.184(b)
8 · Quantity manufactured

Regulation Text

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Open 21 CFR 820.184 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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