SOFIE Co. dba SOFIE
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
- 8285 El Rio Suite 160, Houston, Texas (TX) 77054, United States (USA)
- Operations here
- positron emission tomography drug production
- FDA identifiers
- FEI 3003932395 · DUNS 118258354
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-10-28
- NAIDrug Quality Assurance2017-01-04
- VAIDrug Quality Assurance2016-05-06
- NAIDrug Quality Assurance2012-09-27
Drugs this plant is listed as making
3 distinct drugs across 3 products name this site in their FDA label.
- Ammonia N-13SOFIE Co. dba SOFIE
- Fludeoxyglucose F-18SOFIE Co.
- Piflufolastat F-18Progenics Pharmaceuticals, Inc.
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.