Drug plant · FDA FEI 3003623331
Pcas
ROUTE D AVIGNON, Aramon, France
Problems found, fixed voluntarily at FDA's last inspection, Mar 19, 2021.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
5 drug inspections on record since 2009: 3 with no problems, 2 with minor problems, 0 with serious problems.
What it does, for whom
- Elafibranor: makes the active ingredient and tests it for Ipsen Biopharmaceuticals, Inc. (NDC 15054-0080)
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 19, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 14, 2018 | No problems found | Drug Quality Assurance | — |
| Sep 23, 2016 | No problems found | Drug Quality Assurance | — |
| May 29, 2013 | No problems found | Drug Quality Assurance | — |
| Jun 25, 2009 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.