Drug factory · FDA FEI 3012367823

The University of Texas Southwestern Medical Center

5323 Harry Hines Blvd, Dallas, TX, United States

Problems found, fixed voluntarily at FDA's last inspection, May 15, 2026.

Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.

2 drug inspections on record since 2012: 0 with no problems, 2 with problems fixed voluntarily, 0 with FDA action.

What it does, for whom

Drug	Role	For	NDC
Ammonia N-13	Makes it, tests it, packages it and labels it	The University of Texas Southwestern Medical Center	70681-001

Ended	Result	Program	Problems noted
May 15, 2026	Problems found, fixed voluntarily	Drug Quality Assurance	1
Jan 23, 2012	Problems found, fixed voluntarily	Bioresearch Monitoring	2

From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.

Procedures to Investigate Cause of Non-Conforming Product 21 CFR 212.71(a)
You did not follow procedures to investigate the cause(s) of the nonconforming batch(s) of a PET drug product.

Factors required for approval 21 CFR 50.52
The IRB approved a clinical investigation in which more than minimal risk to children was presented by 1) an intervention or procedure that held out the prospect of direct benefit for the individual subjects, and/or 2) by a monitoring procedure which was likely to contribute to the individual subjects' well-being. However, the IRB did not document that adequate provisions had been made for soliciting the assent of the children and the permission of their parents or guardians, as set forth in 21 CFR 50.55.
Initial and continuing reviews 21 CFR 56.108(a)(1)
The IRB written procedure for conducting its initial and continuing review of research.

Registered with FDA for: analysis; label; pack; positron emission tomography drug production.