FDA Inspection 815125 — Giant Medical
The FDA completed an inspection of Giant Medical on Jan 23, 2013 in Cremona. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 4 citations were issued during this inspection. Product area: Devices.
Inspection details
- Classification
- No Action Indicated (NAI)
- End Date
- Jan 23, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Cremona (Italy)
Citations
| ID | CFR | Description |
|---|---|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 3123 | 21 CFR 820.80(c) | Lack of or inadequate In-process acceptance procedures |
| 3427 | 21 CFR 820.50(a)(2) | Supplier oversight |
| 3666 | 21 CFR 820.20(c) | Management review - Lack of or inadequate procedures |