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FDA Inspection
•Hoxworth Blood Center University of Cincinnati•October 6, 2016

Hoxworth Blood Center University of Cincinnati – FDA Inspection, Oct 6, 2016

Record Details

This FDA Inspection record concerns Hoxworth Blood Center University of Cincinnati, with an inspection on October 6, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Hoxworth Blood Center University of Cincinnati
Inspection Date
October 6, 2016
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Jennifer L. Sheehan (Issuing Officer)
View Company Profile

ID · bf8896f5-4626-4bb3-9a91-9853664bfec2

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
986908
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 606.60(a)Equipment observed, standardized, calibrated

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Hoxworth Blood Center University of Cincinnati

4
DateClassificationOfficeProject area
October 30, 2014NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
November 15, 2012NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
December 8, 2010NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
March 19, 2009NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Hoxworth Blood Center University of Cincinnati
  • FDA Inspection 903234 - 2014-10-30
  • FDA Inspection 807055 - 2012-11-15
  • FDA Inspection 700746 - 2010-12-08
  • FDA Inspection 571094 - 2009-03-19

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