The University of Texas Southwestern Medical Center
A single plant registered with the FDA to make drugs for the US market. Below is where it is and the drugs whose FDA labels list this site as performing a manufacturing step — so if this plant has a problem, these are the products that could be affected.
- Country
- United States
- Registered address
- 5323 Harry Hines Blvd, Dallas, Texas (TX) 75390, United States (USA)
- Operations here
- analysislabelpackpositron emission tomography drug production
- FDA identifiers
- FEI 3012367823 · DUNS 800771545
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2026-05-15
- VAIBioresearch Monitoring2012-01-23
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site in their FDA label.
- Ammonia N-13The University of Texas Southwestern Medical Center
Sources:the establishment's name, address, and country from FDA's Drug Establishments Current Registration Site (DECRS); the drug-to-facility links from DailyMed SPL drug labels, matched by the facility's DUNS number; inspection outcomes from the FDA Data Dashboard, matched by FEI; shortage status from FDA's drug shortage database. More on how this is built. Educational only.