Drug factory · FDA FEI 3008929709
A & M STABTEST Labor für Analytik und Stabilitätsprüfung GmbH
Galileo-Galilei-Strasse 28, Mainz, Germany
Problems found, fixed voluntarily at FDA's last inspection, Jan 19, 2023.
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 |
|---|---|---|---|
| Ropivacaine | Tests it | BioQ Pharma Incorporated | 71807-011 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jan 19, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Oct 9, 2018 | No problems found | Drug Quality Assurance | — |
| Nov 13, 2013 | No problems found | Drug Quality Assurance | — |
| May 3, 2011 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis.