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FDA Inspection
•University of South Alabama Children's and Women's Hospital•May 31, 2013

University of South Alabama Children's and Women's Hospital – FDA Inspection, May 31, 2013

Record Details

This FDA Inspection record concerns University of South Alabama Children's and Women's Hospital, with an inspection on May 31, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
University of South Alabama Children's and Women's Hospital
Inspection Date
May 31, 2013
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 84e012b2-813e-4822-8114-e6dca8faa8dd

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
834005
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

2
  1. 21 CFR 606.160(a)(1)Person performing, test results, interpretation
  2. 21 CFR 211.68(a)Calibration/Inspection/Checking not done

Full citation text and observation details available on the Dashboard.

Other FDA inspections of University of South Alabama Children's and Women's Hospital

7
DateClassificationOfficeProject area
September 18, 2024NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
April 22, 2022NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
January 22, 2019VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 22, 2017VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
February 11, 2015VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 7 other inspections on the company page
Other documents for University of South Alabama Children's and Women's Hospital
  • FDA Inspection 1251679 - 2024-09-18
  • FDA Inspection 1169075 - 2022-04-22
  • FDA Inspection 1076900 - 2019-01-22
  • FDA Inspection 1015575 - 2017-06-22
  • FDA Inspection 913526 - 2015-02-11

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