FDA Inspection 911848 — LeMaitre Vascular, Inc.
The FDA completed an inspection of LeMaitre Vascular, Inc. on Jan 28, 2015 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
- Jan 28, 2015
- Fiscal Year
- 2015
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- North Brunswick, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3130 | 21 CFR 820.100(a) | Lack of or inadequate procedures |
| 3159 | 21 CFR 820.184 | DHR content |
| 3263 | 21 CFR 820.250(b) | Sampling plans |
| 3331 | 21 CFR 820.181 | DMR - not or inadequately maintained |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |