870387
Acme Monaco Corporation — FEI 1293141
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 7, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- New Britain, CT (United States)
Citations
| ID | CFR | Description |
|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3160 | 21 CFR 820.184 | Lack of or inadequate DHR procedures |
| 3193 | 21 CFR 820.30(g) | Design validation - simulated testing |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3678 | 21 CFR 820.30(g) | Design Validation - Risk analysis not performed/inadequate |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |