FDA Inspection 1047145 — DETAX GmbH & Co. KG
The FDA completed an inspection of DETAX GmbH & Co. KG on Apr 6, 2018 in Ettlingen. 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). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Apr 6, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Ettlingen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3190 | 21 CFR 820.30(g) | Design validation acceptance criteria |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3282 | 21 CFR 820.90(a) | Nonconforming product, Lack of or inadequate procedures |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |