FDA Inspection 1056300 — Transmed Medizintechnik
The FDA completed an inspection of Transmed Medizintechnik on Jun 14, 2018 in Bad Wunnenberg. 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). 2 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jun 14, 2018
- Fiscal Year
- 2018
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Bad Wunnenberg (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |