793451
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- August 3, 2012
- Fiscal Year
- 2012
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Palmetto, FL (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3103 | 21 CFR 820.30(i) | Design changes - Lack of or Inadequate Procedures |
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3168 | 21 CFR 820.198(a) | Complaints |
| 3203 | 21 CFR 820.40(b) | Document change records, maintained. |
| 3269 | 21 CFR 820.80(b) | Incoming acceptance records, documentation |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 486 | 21 CFR 820.50(a) | Evaluation of suppliers, contractors, etc., requirements |
| 632 | 21 CFR 803.17(a)(2) | Lack of System for Determining MDR Events |