650674
LeMaitre Vascular, Inc. — FEI 1000121696
Inspection Details
- Classification
- Official Action Indicated (OAI) (OAI)
- End Date
- March 8, 2010
- Fiscal Year
- 2010
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- North Brunswick, NJ (United States)
Citations
| ID | CFR | Description |
|---|
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3142 | 21 CFR 820.150(a) | Storage procedures to avoid release of unsuitable product |
| 3284 | 21 CFR 820.90(a) | Nonconforming product evaluation/investigation |
| 3299 | 21 CFR 820.100(a)(1) | Procedure for analysis of data sources |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 3690 | 21 CFR 820.100(a)(3) | Identification of actions needed |
| 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 |