FDA Inspection 1172108 — LeMaitre Vascular, Inc.
The FDA completed an inspection of LeMaitre Vascular, Inc. on Jun 15, 2022 in Burlington, MA. 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
- Jun 15, 2022
- Fiscal Year
- 2022
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Burlington, MA (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 3108 | 21 CFR 820.70(e) | Contamination control, Lack of or inadequate procedures |
| 3128 | 21 CFR 820.90(a) | Nonconforming product control |
| 3232 | 21 CFR 820.72(a) | Equipment suitability & capability |
| 3696 | 21 CFR 820.100(b) | Documentation |
| 546 | 21 CFR 820.75(a) | Lack of or inadequate process validation |