FDA Inspection
LeMaitre Vascular, Inc.LeMaitre Vascular, Inc. – FDA Inspection, May 16, 2023
Record Details
This FDA Inspection record concerns LeMaitre Vascular, Inc., with an inspection on May 16, 2023, issued by the Center for Devices and Radiological Health, covering devices.
View Company Profile
ID · 0d85c2e6-3c6a-4885-90e7-1d8709edfa0b
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1206543
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
Full citation text and observation details available on the Dashboard.
Other FDA inspections of LeMaitre Vascular, Inc.
10| Date | Classification | Office | Project area |
|---|---|---|---|
| June 15, 2022 | 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 |
Other documents for LeMaitre Vascular, Inc.
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.