861360
Excite Medical of Tampa Bay LLC — FEI 3008816697
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- January 14, 2014
- Fiscal Year
- 2014
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Tampa, FL (United States)
Citations
| ID | CFR | Description |
|---|
| 14712 | 21 CFR 820.184 | DHR - not or inadequately maintained |
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3120 | 21 CFR 820.80(a) | Lack of or inadequate procedures - Acceptance activities |
| 3127 | 21 CFR 820.80(e) | Documentation |
| 3206 | 21 CFR 820.50(b) | Approval, inadequate purchasing data |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 537 | 21 CFR 820.70(a) | Production processes |