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FDA Inspection
•The University of Texas Medical Branch at Galveston•March 21, 2012

The University of Texas Medical Branch at Galveston – FDA Inspection, Mar 21, 2012

Record Details

This FDA Inspection record concerns The University of Texas Medical Branch at Galveston, with an inspection on March 21, 2012, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
The University of Texas Medical Branch at Galveston
Inspection Date
March 21, 2012
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 6a1a0d12-b422-4285-8566-da683c058e74

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
773236
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

2
  1. 21 CFR 606.60(b)Equipment calibration frequency
  2. 21 CFR 606.100(b)(14)QC procedures for supplies and reagents

Full citation text and observation details available on the Dashboard.

Other FDA inspections of The University of Texas Medical Branch at Galveston

2
DateClassificationOfficeProject area
March 13, 2014NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
February 25, 2010NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
Other documents for The University of Texas Medical Branch at Galveston
  • FDA Inspection 869813 - 2014-03-13
  • FDA Inspection 649025 - 2010-02-25

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