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
- 5900b Obata Way, Gilroy, California (CA) 95020, United States (USA)
- Operations here
- positron emission tomography drug production
- FDA identifiers
- FEI 3006246010 · DUNS 832599976
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2025-08-07
- VAIDrug Quality Assurance2019-02-05
- VAIDrug Quality Assurance2016-08-04
- VAIDrug Quality Assurance2014-02-14
Drugs this plant is listed as making
3 distinct drugs across 3 products name this site in their FDA label.
- 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.