816447
GS Medical Packaging Inc — FEI 3003067378
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- January 31, 2013
- Fiscal Year
- 2013
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Etobicoke (Canada)
Citations
| ID | CFR | Description |
|---|
| 14713 | 21 CFR 820.198(a) | Lack of or inadequate complaint procedures |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 630 | 21 CFR 803.17 | Lack of Written MDR Procedures |
| 732 | 21 CFR 803.50(a)(2) | Individual Report of Malfunction |