Skyepharma Production Sas
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
- ZONE INDUSTRIELLE CHESNES OUEST 55 RUE DU MONTMURIER, ST QUENTIN FALLAVIER, 38070, France (FRA)
- Operations here
- analysislabelmanufacturepackrelabel
- FDA identifiers
- FEI 3002808180 · DUNS 383630456
FDA inspection history
Outcomes of closed FDA inspections at this site (drug and biologic program areas).
- VAIDrug Quality Assurance2023-10-27
- NAIDrug Quality Assurance2019-09-06
- NAIDrug Quality Assurance2015-06-19
- NAIDrug Quality Assurance2013-05-31
- VAIDrug Quality Assurance2010-04-02
Drugs this plant is listed as making
3 distinct drugs across 8 products name this site in their FDA label.
- Bismuth Subcitrate Potassium, Metronidazole and Tetracycline HydrochlorideH2-Pharma, LLC
- Bismuth Subcitrate Potassium, Metronidazole, And Tetracycline HydrochlorideH2-Pharma, LLC
- sotalol hydrochlorideLegacy Pharma USA, 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.