FDA Inspection
LeMaitre Vascular, Inc.LeMaitre Vascular, Inc. – FDA Inspection, Jun 15, 2022
Record Details
This FDA Inspection record concerns LeMaitre Vascular, Inc., with an inspection on June 15, 2022, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- LeMaitre Vascular, Inc.
- Inspection Date
- June 15, 2022
- Product Type
- Devices
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ID · e426d7a8-1601-43db-8fa4-0cf83f6e8636
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1172108
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
5- 21 CFR 820.75(a)Lack of or inadequate process validation
- 21 CFR 820.72(a)Equipment suitability & capability
- 21 CFR 820.100(b)Documentation
- 21 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
- 21 CFR 820.90(a)Nonconforming product control
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Other FDA inspections of LeMaitre Vascular, Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| May 16, 2023 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
| July 26, 2021 | NAI | Center for Biologics Evaluation and Research | Vaccines and Allergenic Products |
| August 27, 2020 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| August 1, 2017 | NAI | Center for Devices and Radiological Health | Compliance: Devices |
| March 4, 2013 | VAI | Center for Devices and Radiological Health | Compliance: Devices |
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