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21 CFR 803.17

Lack of Written MDR Procedures

  • Inspections citing it: 2,244
  • Of those classified, ended OAI: 23%
  • Last cited: FY2027

Inspections Citing It by Fiscal Year

Sites in and outside the US, FY2018 to Oct 20, 2026.

Paragraphs Cited

As FDA posts them, all years.

803.17
1,701 · Lack of Written MDR Procedures
803.17(a)(1)
225 · Lack of System for Event Evaluations
803.17(a)(2)
149 · Lack of System for Determining MDR Events
803.17(a)(3)
90 · Lack of System for Timely Submission of Reports
803.17(b)(1)
58 · Info evaluated to determine if event was reportable
803.17(b)(2)
21 · Reports and information documentation

Regulation Text

eCFR did not answer; open it on eCFR

Open 21 CFR 803.17 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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