FDA Inspection 803114 — FSSB Chirurgische Nadeln Gmbh
The FDA completed an inspection of FSSB Chirurgische Nadeln Gmbh on Sep 20, 2012 in Jestetten. The inspection was classified OAI (Official Action Indicated — regulatory and/or administrative actions are recommended). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- Official Action Indicated (OAI)
- End Date
- Sep 20, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Jestetten (Germany)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3231 | 21 CFR 820.70(i) | Documentation of software validation |
| 3263 | 21 CFR 820.250(b) | Sampling plans |