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FDA Inspection
•Emory Decatur Hospital•March 13, 2009

Emory Decatur Hospital – FDA Inspection, Mar 13, 2009

Record Details

This FDA Inspection record concerns Emory Decatur Hospital, with an inspection on March 13, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Emory Decatur Hospital
Inspection Date
March 13, 2009
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · d4e6104b-3b64-4f0a-b25b-45e70ad473ac

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
571703
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

2
  1. 21 CFR 606.171Biological product deviation report
  2. 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Emory Decatur Hospital

5
DateClassificationOfficeProject area
February 5, 2020NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
October 20, 2017NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
October 22, 2015NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
July 24, 2013NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
January 21, 2011NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for Emory Decatur Hospital
  • FDA Inspection 1119711 - 2020-02-05
  • FDA Inspection 1031430 - 2017-10-20
  • FDA Inspection 946232 - 2015-10-22
  • FDA Inspection 841908 - 2013-07-24
  • FDA Inspection 706965 - 2011-01-21

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