21 CFR 803.52

Patient Name or Other Identifier

Inspections citing it: 29
Of those classified, ended OAI: 41%
Last cited: FY2025

Inspections Citing It by Fiscal Year

Sites in and outside the US, FY2017 to Oct 20, 2026.

02018

22020

02022

02024

02026

Paragraphs Cited

As FDA posts them, all years.

803.52(a)(1): 8 · Patient Name or Other Identifier
803.52(f)(1): 6 · Type of Reportable Event
803.52(b)(2): 5 · Death
803.52(e)(1): 5 · Contact Office Name and Address
803.52(f)(6): 5 · Evaluation Codes

Regulation Text

eCFR did not answer; open it on eCFR

Open 21 CFR 803.52 on eCFR

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