Drug factory · FDA FEI 3003183252
Haupt Pharma Wuelfing GmbH
Bethelner Landstraße 18, Gronau (Leine), Germany
Problems found, fixed voluntarily at FDA's last inspection, Jun 6, 2023.
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 2008: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Bosentan | Makes it | Actelion Pharmaceuticals US, Inc. | 66215-101, 66215-102 |
| Ferric Ferrocyanide | Makes it, tests it, packages it and labels it | Heyl Chem.-pharm. Fabrik GmbH & Co. KG | 58060-002 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Jun 6, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Dec 7, 2018 | No problems found | Drug Quality Assurance | — |
| Mar 17, 2017 | No problems found | Drug Quality Assurance | — |
| Mar 28, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Apr 20, 2012 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 6, 2008 | 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.
Mar 28, 2014 inspection
- Procedures not in writing, fully followed 21 CFR 211.22(d)
The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed. - Cleaning / Sanitizing / Maintenance 21 CFR 211.67(a)
Equipment and utensils are not cleaned 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.