FDA Inspection 839517 — Faulhaber Pinzetten KG
The FDA completed an inspection of Faulhaber Pinzetten KG on Jul 4, 2013 in Frittlingen. 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). 10 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Jul 4, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Frittlingen (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 2430 | 21 CFR 820.30(b) | Design plans - Lack of or inadequate |
| 2557 | 21 CFR 820.30(c) | Design input - documentation |
| 2602 | 21 CFR 820.30(d) | Design output - review and approval |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3204 | 21 CFR 820.40(b) | Change records, content |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 3375 | 21 CFR 820.198(e) | Records of complaint investigation |
| 4057 | 21 CFR 820.20(a) | Management ensuring quality policy is understood |