Drug factory · FDA FEI 3002806853
Patheon Austria GmbH & CoKG
St.-Peter-Strasse 25, Linz, Austria
Problems found, fixed voluntarily at FDA's last inspection, Sep 12, 2024.
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: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Colesevelam | Makes the active ingredient | Bionpharma Inc. | 69452-158 |
| Meropenem and Vaborbactam | Makes the active ingredient and tests it | Melinta Therapeutics, LLC | 70842-120 |
| Neostigmine | Makes it | Exela Pharma Sciences, LLC | 51754-1240 |
| Pacritinib | Makes the active ingredient and tests it | Sobi, Inc. | 72482-100 |
| Ponesimod | Makes the active ingredient and tests it | Janssen Pharmaceuticals, Inc. | 50458-707, 50458-720 |
| Tapinarof | Makes the active ingredient and tests it | Organon LLC | 81672-5051 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 12, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 30, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 29, 2015 | No problems found | Drug Quality Assurance | — |
| Jun 1, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 8, 2009 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.