Drug factory · FDA FEI 3002553230
Chemcon GmbH
Engesserstr. 4b, Freiburg im Breisgau, Germany
Problems found, fixed voluntarily at FDA's last inspection, Sep 8, 2022.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2011: 3 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Oteseconazole | Tests it | Mycovia Pharmaceuticals, Inc. | 74695-823 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Sep 8, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 26, 2018 | No problems found | Drug Quality Assurance | — |
| Mar 27, 2014 | No problems found | Drug Quality Assurance | — |
| Jul 7, 2011 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis; api manufacture.