FDA Inspection 930835 — Miltenyi Biotec Gmbh
The FDA completed an inspection of Miltenyi Biotec Gmbh on May 29, 2015 in Bergisch Gladbach. 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). 4 citations were issued during this inspection. Product area: Biologics.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- May 29, 2015
- Fiscal Year
- 2015
- Product Type
- Biologics
- Project Area
- Blood and Blood Products
- Location
- Bergisch Gladbach (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3343 | 21 CFR 820.198(e) | Maintained |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 631 | 21 CFR 803.17(a)(1) | Lack of System for Event Evaluations |