FDA Inspection
University of Texas Southwestern Medical Center, TheUniversity of Texas Southwestern Medical Center, The – FDA Inspection, Aug 2, 2017
Record Details
This FDA Inspection record concerns University of Texas Southwestern Medical Center, The, with an inspection on August 2, 2017, issued by the Dallas District Office, covering human drugs.
- Inspection Date
- August 2, 2017
- Product Type
- Human Drugs
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ID · a20fe95e-6798-4cd5-b14d-ccd2a0535881
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1021093
- FDA center
- Human Drugs
- Project area
- Generic Drug Evaluation
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 212.20(b)Examine, approve or reject
- 21 CFR 212.30(a)Prevention of contamination
- 21 CFR 212.60(b)Testing Procedures- Conformance to Standards
- 21 CFR 212.60(g)(3)Complete record of all laboratory test data
- 21 CFR 212.71(b)Documentation of Non-Conforming Product Investigation
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Other FDA inspections of University of Texas Southwestern Medical Center, The
6| Date | Classification | Office | Project area |
|---|---|---|---|
| May 15, 2026 | Not classified | Dallas District Office | Drug Quality Assurance |
| February 9, 2023 | Not classified | Dallas District Office | |
| September 13, 2019 | Not classified | Dallas District Office | |
| November 9, 2018 | Not classified | Dallas District Office | |
| October 20, 2015 | NAI | Center for Devices and Radiological Health | Bioresearch Monitoring |
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 946171 - 2015-10-20
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