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1093994

Oklahoma Blood Institute — FEI 1626009

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
June 7, 2019
Fiscal Year
2019
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Oklahoma City, OK (United States)

Facility

Other inspections at this facility

  • 1231637 (NAI Tue Aug 20 2024 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 1023507 (NAI Tue Jun 20 2017 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 945662 (VAI Thu Aug 20 2015 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 876145 (NAI Wed May 07 2014 00:00:00 GMT+0000 (Coordinated Universal Time))
  • 810435 (NAI Thu Oct 11 2012 00:00:00 GMT+0000 (Coordinated Universal Time))

Citations

IDCFRDescription
15421 CFR 606.160(a)(1)Concurrent documentation
1804821 CFR 606.145(a)Control risk of contamination
1805321 CFR 606.145(d)Infection in bloodstream
1808221 CFR 630.10(e)(2)Additional Medical Assessment Factors
442521 CFR 606.60(a)Equipment observed, standardized, calibrated
926221 CFR 610.40(b)One or more approved screening tests
9821 CFR 606.100(c)Thorough investigations