Drug factory · FDA FEI 3006165521
Microcoat Biotechnologie GmbH
Am Rusgraben 1, Bernried, Germany
Problems found, fixed voluntarily at FDA's last inspection, Jun 27, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2023: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Tislelizumab | Tests it | BeOne Medicines USA, Inc. | 72579-121, 72579-125 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 27, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 15, 2023 | No problems found | Drug Quality Assurance | — |
Registered with FDA for: analysis.