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FDA Inspection
•University of Texas Southwestern Medical Center, The•January 23, 2012

University of Texas Southwestern Medical Center, The – FDA Inspection, Jan 23, 2012

Record Details

This FDA Inspection record concerns University of Texas Southwestern Medical Center, The, with an inspection on January 23, 2012, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
University of Texas Southwestern Medical Center, The
Inspection Date
January 23, 2012
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 01a51a41-d95c-4730-a8b4-586f064fd778

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
764442
FDA center
Human Drugs
Project area
Bioresearch Monitoring

FDA Citations

2
  1. 21 CFR 50.52Factors required for approval
  2. 21 CFR 56.108(a)(1)Initial and continuing reviews

Full citation text and observation details available on the Dashboard.

Other FDA inspections of University of Texas Southwestern Medical Center, The

6
DateClassificationOfficeProject area
May 15, 2026Not classifiedDallas District OfficeDrug Quality Assurance
February 9, 2023Not classifiedDallas District Office
September 13, 2019Not classifiedDallas District Office
November 9, 2018Not classifiedDallas District Office
August 2, 2017OAIDallas District OfficeGeneric Drug Evaluation
View all 6 other inspections on the company page
Other documents for University of Texas Southwestern Medical Center, The
  • FDA Inspection 1317258 - 2026-05-15
  • FDA Inspection 1198460 - 2023-02-09
  • FDA Inspection 1101987 - 2019-09-13
  • FDA Inspection 1073752 - 2018-11-09
  • FDA Inspection 1021093 - 2017-08-02

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