Drug factory · FDA FEI 3009238374
medac pharma production GmbH
Am Pharmapark, Dessau-Rosslau, Saxony-Anhalt, Germany
Problems found, fixed voluntarily at FDA's last inspection, Oct 17, 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: 2 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Treosulfan | Makes it and tests it | Medexus Pharma, Inc. | 59137-335, 59137-365 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Oct 17, 2024 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 3, 2021 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Sep 27, 2019 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Nov 7, 2017 | Problems found, fixed voluntarily | Drug Quality Assurance | 2 |
| Apr 17, 2014 | No problems found | Drug Quality Assurance | — |
| Oct 4, 2012 | No problems found | 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.
Nov 7, 2017 inspection
- Procedures for sterile drug products 21 CFR 211.113(b)
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed. - Training , Education , Experience overall 21 CFR 211.25(a)
Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.
Registered with FDA for: analysis; manufacture.