Drug factory · FDA FEI 3006010798
Haupt Pharma Muenster GmbH
Schleebrueggenkamp 15, Muenster, Germany
Problems found, fixed voluntarily at FDA's last inspection, Nov 20, 2024.
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 2012: 2 with no problems, 3 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Drospirenone and Estetrol | Makes it, tests it and packages it | Mayne Pharma Inc. | 51862-258 |
| Ethinyl Estradiol and Levonorgestrel | Makes it | Ohm Laboratories Inc. | 51660-572 |
| Ethinyl Estradiol and Norgestimate | Makes it, tests it and packages it | Amneal Pharmaceuticals | 69238-1551 |
| Norethindrone | Makes it | Ohm Laboratories Inc. | 51660-127 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Nov 20, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 24, 2021 | No problems found | Drug Quality Assurance | — |
| Jul 6, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Mar 21, 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.
Jul 6, 2018 inspection
- Absence of Written Procedures 21 CFR 211.100(a)
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess. - 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. - Computer control of master formula records 21 CFR 211.68(b)
Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.
Registered with FDA for: analysis; label; manufacture; pack.