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21 CFR 820.181

DMR - not or inadequately maintained

  • Inspections citing it: 890
  • Of those classified, ended OAI: 27%
  • 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.

820.181
795 · DMR - not or inadequately maintained
820.181(a)
64 · DMR device specifications
820.181(c)
17 · DMR QA procedures and specifications
820.181(b)
14 · DMR production process specifications

Regulation Text

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Open 21 CFR 820.181 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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