FDA Inspection 794094 — Belimed AG
The FDA completed an inspection of Belimed AG on Aug 10, 2012 in Sulgen. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Aug 10, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Sulgen (Switzerland)
Citations
| ID | CFR | Description |
|---|---|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2604 | 21 CFR 820.30(e) | Design review - Lack of or inadequate procedures |
| 2650 | 21 CFR 820.30(f) | Design verification - Lack of or inadequate procedures |
| 3101 | 21 CFR 820.30(g) | Design validation- Lack of or inadequate procedures |
| 3285 | 21 CFR 820.90(b)(2) | Product rework procedures, Lack of or inadequate procedures |
| 3355 | 21 CFR 820.198(f) | Records accessibility |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |