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University of Texas Southwestern Medical Center, The, Dallas, TX – FDA Inspections

Inspection records and compliance data for University of Texas Southwestern Medical Center, The in Dallas, Texas. 7 FDA inspections on record (1 OAI), 4 Form 483s, last inspected May 15, 2026.

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Company Profile

This profile covers University of Texas Southwestern Medical Center, The based in Dallas, Texas, United States.

FDA Inspection History

FDA inspections
7
OAI
1
VAI
1
NAI
1
Unclassified
4
Form 483s
4
Warning letters
0

First inspected January 23, 2012. Last inspected May 15, 2026.

Most cited issue areas

  • Complete record of all laboratory test data1 inspection
  • Documentation of Non-Conforming Product Investigation1 inspection
  • Examine, approve or reject1 inspection

FDA inspections (7)

DateResultFDA center(s)Insp. #
May 15, 2026Not classifiedHuman Drugs · Drug Quality Assurance1317258
February 9, 2023Not classifiedBiologics1198460
September 13, 2019Not classifiedHuman Drugs1101987
November 9, 2018Not classifiedHuman Drugs1073752
August 2, 2017OAIHuman Drugs · Generic Drug Evaluation1021093
October 20, 2015NAIMedical Devices & Rad Health · Bioresearch Monitoring946171
January 23, 2012VAIHuman Drugs · Bioresearch Monitoring764442
FDA documents

Form 483s (2)

  • Form 483s · May 15, 2026
  • Form 483s · September 9, 2019
People (3)
Kentra D. Hewitt, Recall Coordinator/CO
Person
Shanna N. Purdy
Person
Shelby N. Turner
Person
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Company Information

Name

University of Texas Southwestern Medical Center, The

FEI Number

3012367823

Address

2201 Inwood Rd, Dallas, Texas 75235-7320, United States

Country

United States

ID: cccba9bc-b8f4-4a80-b581-c6faa059e049

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