Drug factory · FDA FEI 3002806849
Wasserburger Arzneimittelwerk GmbH
Herderstrasse 2, Wasserburg a Inn, Germany
No problems found at FDA's last inspection, May 2, 2024.
No Action Indicated: inspectors found no objectionable conditions.
5 drug inspections on record since 2010: 1 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Deferoxamine | Makes it, tests it and packages it | Mitem Pharma | 87081-467 |
| Epoprostenol | Makes it, tests it, packages it and labels it | Actelion Pharmaceuticals US, Inc. | 66215-402 |
| Sugammadex | Makes it and tests it | Caraco Pharmaceutical Laboratories, Ltd. | 62756-079 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| May 2, 2024 | No problems found | Drug Quality Assurance | — |
| Jan 23, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Oct 27, 2015 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 10, 2013 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 9, 2010 | 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.
Jan 23, 2018 inspection
- Complete Test Data 21 CFR 211.194(a)(4)
Laboratory records are deficient in that they do not include a complete record of all data obtained during testing. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not maintained at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.
Registered with FDA for: analysis; label; manufacture; pack.