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FDA Inspection
•Henry Ford Hospital•July 19, 2019

Henry Ford Hospital – FDA Inspection, Jul 19, 2019

Record Details

This FDA Inspection record concerns Henry Ford Hospital, with an inspection on July 19, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Henry Ford Hospital
Inspection Date
July 19, 2019
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
People
  • Emily B. Camire (Issuing Officer)
  • Matthew J. Gretkierewicz (Company Rep)
View Company Profile

ID · 4d43c028-34fd-4033-a2f9-81f24f506f7f

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1096746
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 Henry Ford Hospital

5
DateClassificationOfficeProject area
May 31, 2023NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
January 11, 2017NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
February 20, 2015VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
December 7, 2012VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
August 11, 2010NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Henry Ford Hospital
  • FDA Inspection 1209378 - 2023-05-31
  • FDA Inspection 997379 - 2017-01-11
  • FDA Inspection 915113 - 2015-02-20
  • FDA Inspection 809591 - 2012-12-07
  • FDA Inspection 676203 - 2010-08-11

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