Astrea Fontaine
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
- France
- Registered address
- Site de Fontaine Rue Des Pres Potets, Fontaine Les Dijon, 21121, France (FRA)
- Operations here
- analysislabelmanufacturepack
- FDA identifiers
- FEI 3002807473 · DUNS 260428962
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2024-09-13
- VAIDrug Quality Assurance2020-12-11
- VAIDrug Quality Assurance2017-11-10
- VAIDrug Quality Assurance2016-01-22
Drugs this plant is listed as making
2 distinct drugs across 5 products name this site in their FDA label.
- PacritinibSobi, Inc.
- tetrabenazineLundbeck Pharmaceuticals LLC
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.