FDA Inspection 1325342 — LeMaitre Vascular, Inc.
The FDA completed an inspection of LeMaitre Vascular, Inc. on Jun 25, 2026 in North Brunswick, NJ. The inspection was classified NAI (No Action Indicated — no objectionable conditions or practices were found during the inspection). 8 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI)
- End Date
- Jun 25, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- North Brunswick, NJ (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23083 | ISO 13485:2016 Clause 6.4.2 | Arrangements for control of contaminated product not planned and documented |
| 23104 | ISO 13485:2016 Clause 7.3.3 | Design and development inputs do not include all requirements |
| 23155 | ISO 13485:2016 Clause 7.5.1 | Production and service provision not adequate |
| 23189 | ISO 13485:2016 Clause 7.5.11 | Procedures for preserving the conformity of product not documented |
| 23213 | ISO 13485:2016 Clause 8.2.1 | Information gathered in feedback process not used as input into risk management |
| 23238 | ISO 13485:2016 Clause 8.3.1 | Nonconforming product not adequately evaluated |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |
| 23261 | ISO 13485:2016 Clause 8.5.3 | Preventive action procedures not documented |