Drug factory · FDA FEI 3003282622
Daiichi Sankyo Europe GmbH
Luitpoldstr. 1, Pfaffenhofen a.d.Ilm, Germany
Problems found, fixed voluntarily at FDA's last inspection, Jul 18, 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 2010: 4 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Prasugrel | Makes it and tests it | Cosette Pharmaceuticals, Inc. | 0713-0881, 0713-0882 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jul 18, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Oct 19, 2018 | No problems found | Drug Quality Assurance | — |
| May 15, 2014 | No problems found | Drug Quality Assurance | — |
| Sep 20, 2012 | No problems found | Drug Quality Assurance | — |
| Jan 29, 2010 | No problems found | 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.
Jul 18, 2025 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed. - Complete test data included in records 21 CFR 211.194(a)
Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards. - Written procedures not established/followed 21 CFR 211.67(b)
Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.
Registered with FDA for: analysis; label; manufacture; pack.