FDA Inspection 671607 — Gynetics Medical Products NV
The FDA completed an inspection of Gynetics Medical Products NV on June 10, 2010 in Lommel. The inspection was classified OAI (Official Action Indicated — objectionable conditions were found and regulatory action is recommended). 6 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- June 10, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Lommel (Belgium)
Citations
| ID | CFR | Description |
|---|---|---|
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3111 | 21 CFR 820.70(f) | Buildings |
| 3113 | 21 CFR 820.70(g) | Equipment design and installation |
| 3218 | 21 CFR 820.70(c) | Environmental control system-documentation/review inspection |
| 3415 | 21 CFR 820.22 | Quality Audit/Reaudit - conducted |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |