FDA Inspection 1030971 — BioChem Labor Fur Biologische Und Chemische Analytik GMBH
The FDA completed an inspection of BioChem Labor Fur Biologische Und Chemische Analytik GMBH on Nov 7, 2017 in Karlsruhe. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 1 citation was issued during this inspection. Product area: Drugs.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 7, 2017
- Fiscal Year
- 2018
- Product Type
- Drugs
- Project Area
- Drug Quality Assurance
- Location
- Karlsruhe (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 1809 | 21 CFR 211.160(a) | Following/documenting laboratory controls |