781953
ZOLL Medical Corporation — FEI 1220908
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- April 19, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Chelmsford, MA (United States)
Citations
| ID | CFR | Description |
|---|
| 14715 | 21 CFR 820.30(d) | Design output - Lack of or inadequate procedures |
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3121 | 21 CFR 820.80(b) | Lack of or inadequate receiving acceptance procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3172 | 21 CFR 820.198(c) | Investigation of device failures |
| 3207 | 21 CFR 820.50(b) | Supplier notification of changes |
| 539 | 21 CFR 820.70(b) | Production and Process Change Procedures, lack of or Inad. |