FDA Inspection 704445 — LeMaitre Vascular, Inc.
The FDA completed an inspection of LeMaitre Vascular, Inc. on Dec 20, 2010 in North Brunswick, NJ. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 5 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Dec 20, 2010
- Fiscal Year
- 2011
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- North Brunswick, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2350 | 21 CFR 820.25(b) | Training - Lack of or inadequate procedures |
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3118 | 21 CFR 820.75(a) | Documentation |
| 3434 | 21 CFR 820.75(c) | Documentation - review in response to changes or deviations |
| 541 | 21 CFR 820.70(c) | Environmental control Lack of or inadequate procedures |