21 CFR 640.61

Explanation of hazards

Inspections citing it: 15
Of those classified, ended OAI: 7%

Inspections Citing It by Fiscal Year

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

02018

02020

02022

02024

02026

Regulation Text

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Open 21 CFR 640.61 on eCFR

Recently Cited Sites

Newest inspections citing this section; each opens the site

UC Health Poudre Valley HospitalUnited States · Nov 30, 2015
Octapharma Plasma IncUnited States · Apr 1, 2015
Penrose-St Francis Health Services Blood BankUnited States · Mar 31, 2015
Scantibodies Laboratory, Inc.United States · Jun 16, 2014

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