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
- 60H Commerce Way, Totowa, New Jersey (NJ) 07512, United States (USA)
- Operations here
- positron emission tomography drug production
- FDA identifiers
- FEI 3008415560 · DUNS 928455851
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-08-11
- NAIDrug Quality Assurance2017-06-28
- VAIDrug Quality Assurance2015-05-15
- NAIDrug Quality Assurance2012-09-27
Drugs this plant is listed as making
2 distinct drugs across 2 products name this site in their FDA label.
- 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.