Pcas
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 β so if this plant has a problem, these are the products that could be affected.
- Country
- France
- Registered address
- ROUTE D AVIGNON, ARAMON, Gard 30390, France (FRA)
- Operations here
- analysisapi manufacture
- FDA identifiers
- FEI 3003623331 Β· DUNS 276311742
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2021-03-19
- NAIDrug Quality Assurance2018-09-14
- NAIDrug Quality Assurance2016-09-23
- NAIDrug Quality Assurance2013-05-29
- VAIDrug Quality Assurance2009-06-25
Drugs this plant is listed as making
1 distinct drugs across 1 products name this site in their FDA label.
- elafibranorIpsen Biopharmaceuticals, 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.