21 CFR 640.3
Donor suitability procedures not followed
- Inspections citing it: 84
- Of those classified, ended OAI: 10%
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.
- 640.3(a)(1)
- 48 · Donor suitability procedures not followed
- 640.3(a)
- 16 · Donor suitability by means of medical history
- 640.3(f)
- 8 · Donations in less than eight weeks
- 640.3(b)(6)
- 7 · Qualifications of donor - disease transmissible by blood
- 640.3(c)(2)
- 5 · History of viral hepatitis - close contact
Regulation Text
eCFR did not answer; open it on eCFRRecently Cited Sites
Newest inspections citing this section; each opens the site- UC Health Poudre Valley HospitalUnited States · Nov 30, 2015
- Staten Island University Hospital Northwell HealthUnited States · Feb 5, 2015
- Emerson Health HospitalUnited States · Jan 13, 2015
- Blood Assurance IncUnited States · Sep 19, 2014
- Danville Regional Medical Center/Blood BankUnited States · Mar 3, 2014
- ImpactLifeUnited States · Jun 14, 2013
- DLP Twin County Regional Healthcare, LLCUnited States · May 13, 2013
- Community Blood Bank of Erie CountyUnited States · Apr 26, 2013
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