FDA Inspection 953618 — MAQUET GMBH
The FDA completed an inspection of MAQUET GMBH on Nov 19, 2015 in Rastatt. 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). 3 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Nov 19, 2015
- Fiscal Year
- 2016
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Rastatt (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3426 | 21 CFR 820.50(a)(1) | Documented evaluation |