840237
Atrium Medical Corporation — FEI 3011175548
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- October 1, 2013
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Merrimack, NH (United States)
Citations
| ID | CFR | Description |
|---|
| 3117 | 21 CFR 820.70(i) | Software validation for automated processes |
| 3119 | 21 CFR 820.75(b) | Lack/Inad procedure-Monitoring/Control of Validated Proces |
| 3125 | 21 CFR 820.80(d) | Lack of or inadequate final acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |
| 731 | 21 CFR 803.50(a)(1) | Report of Death or Serious Injury |