Drug factory · FDA FEI 3003732290
Rottendorf Pharma GmbH
Ostenfelder Strasse 51-61, Ennigerloh, Germany
Problems found, fixed voluntarily at FDA's last inspection, Mar 14, 2024.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
6 drug inspections on record since 2012: 1 with no problems, 5 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Cabozantinib | Makes it | Exelixis, Inc. | 42388-023, 42388-024, 42388-025 |
| Empagliflozin and Linagliptin | Makes it, packages it and labels it | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0164, 0597-0182 |
| Hydrochlorothiazide and Telmisartan | Makes it, packages it and labels it | Boehringer Ingelheim Pharmaceuticals, Inc. | 0597-0042, 0597-0043, 0597-0044 |
| Tacrolimus | Makes it, tests it, packages it and labels it | Veloxis Pharmaceuticals, Inc | 68992-3010, 68992-3040, 68992-3075 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 14, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| May 6, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 21, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 3, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Mar 14, 2014 | No problems found | Drug Quality Assurance | — |
| Mar 30, 2012 | 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.
Feb 3, 2017 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not fully followed. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned and 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.