Drug factory · FDA FEI 3004512725
Charles River Laboratories Germany GmbH
Max-Planck-Str. 15 a-b, Erkrath, Germany
Problems found, fixed voluntarily at FDA's last inspection, Aug 20, 2025.
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 2011: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Apadamtase Alfa | Tests it | Takeda Pharmaceuticals America, Inc. | 64764-140, 64764-145 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Aug 20, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 24, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 15, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Mar 4, 2015 | No problems found | Drug Quality Assurance | — |
| Sep 23, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Dec 15, 2017 inspection
- Written records kept in individual logs 21 CFR 211.182
Written records of major equipment cleaning and use are not included in individual equipment logs.
Registered with FDA for: analysis.