Drug factory · FDA FEI 3003585629
Laborchemie Apolda GmbH
Utenbacher Straße 72-74, Apolda, Germany
Problems found, fixed voluntarily at FDA's last inspection, Mar 27, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
4 drug inspections on record since 2011: 0 with no problems, 4 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Ferric Ferrocyanide | Makes the active ingredient | Heyl Chem.-pharm. Fabrik GmbH & Co. KG | 58060-002 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Mar 27, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Aug 31, 2018 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 27, 2014 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
| Jun 30, 2011 | Problems found, fixed voluntarily | Drug Quality Assurance | — |
Registered with FDA for: api manufacture.