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
- 64 Medical Center Drive Rm B042, Morgantown, West Virginia (WV) 26506, United States (USA)
- Operations here
- positron emission tomography drug production
- FDA identifiers
- FEI 3005705842 · DUNS 078623800
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-08-28
- NAIDrug Quality Assurance2016-03-18
- NAIDrug Quality Assurance2014-06-06
- VAIDrug Quality Assurance2012-08-16
Drugs this plant is listed as making
4 distinct drugs across 4 products name this site in their FDA label.
- Ammonia N-13SOFIE Co. dba SOFIE
- Fludeoxyglucose F-18SOFIE Co.
- Piflufolastat F-18Progenics Pharmaceuticals, Inc.
- Sodium Fluoride F-18SOFIE Co.
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.