Atlas

Form 483

University of Texas Southwestern Medical Center, The Form 483, 2026-05-15

FDA issued a Form 483 to University of Texas Southwestern Medical Center, The on 2026-05-15 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

University of Texas Southwestern Medical Center, The · Dallas, United States · Issued May 15, 2026

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

15 May 2026
21 CFR 212.71(a)

Procedures to Investigate Cause of Non-Conforming Product

Cited by Shelby N Turner

Inspected site

UOUniversity of Texas Southwestern Medical Center, TheDallas, United States

Inspection team

SNShelby N Turner

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 212.71(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere