Drug factory · FDA FEI 3002320821
Thymoorgan GMBH Pharmazie
Schiffgraben 23, Goslar OT Vienenburg, Germany
Problems found, fixed voluntarily at FDA's last inspection, Mar 26, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
9 drug inspections on record since 2010: 3 with no problems, 6 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Azacitidine | Makes it, tests it, packages it and labels it | Hikma Pharmaceuticals USA Inc. | 0143-9606 |
| Cisplatin | Makes it, tests it, packages it and labels it | Hikma Pharmaceuticals USA Inc. | 0143-9504, 0143-9505 |
| Floxuridine | Makes it, tests it, packages it and labels it | JND Therapeutics, Inc. | 81643-9270 |
| Irinotecan | Makes it, tests it, packages it and labels it | Hikma Pharmaceuticals USA Inc. | 0143-9583, 0143-9701, 0143-9702 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 26, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 25, 2023 | Problems found, fixed voluntarily | Drug Quality Assurance | 3 |
| Oct 6, 2022 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 20, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Apr 23, 2018 | No problems found | Drug Quality Assurance | — |
| Dec 16, 2016 | No problems found | Drug Quality Assurance | — |
| Sep 24, 2015 | No problems found | Drug Quality Assurance | — |
| May 22, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Feb 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.
Apr 25, 2023 inspection
- SOPs not followed / documented 21 CFR 211.100(b)
Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance. - Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed. - Environmental Monitoring System 21 CFR 211.42(c)(10)(iv)
Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.
Registered with FDA for: analysis; label; manufacture; pack.