FDA Inspection 628165 — FSSB Chirurgische Nadeln Gmbh
The FDA completed an inspection of FSSB Chirurgische Nadeln Gmbh on Oct 22, 2009 in Jestetten. 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: Devices.
Inspection details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Oct 22, 2009
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Jestetten (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3241 | 21 CFR 820.72(b)(1) | Calibration standard traceability |
| 3303 | 21 CFR 820.100(a)(4) | Verify, validate change {see also 820.100(a)} |