# FDA 483 - LeMaitre Vascular, Inc. - May 16, 2023

Source: https://www.globalkeysolutions.net/records/483/lemaitre-vascular-inc/b27b211f-dee9-4c29-8082-9ed4b6ffe155

> FDA 483 for LeMaitre Vascular, Inc. on May 16, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: LeMaitre Vascular, Inc.
- Inspection Date: 2023-05-16
- Product Type: device
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: LeMaitre Vascular, Inc. in Burlington, MA, a manufacturer of Class II medical devices, was cited for inadequate complaint handling procedures during an FDA inspection. The firm failed to follow its own Complaint Handling Procedure, leading to significant delays in closing both MDR and non-MDR related complaints. This indicates a breakdown in their quality system regarding complaint management.

## Related Documents

- [WARNING_LETTER - 2025-04-16](https://www.globalkeysolutions.net/records/warning_letter/lemaitre-vascular-inc/3000c09b-7700-4856-95f0-dba90be8ec1e)

## Related Officers

- [Sunita Pandey](https://www.globalkeysolutions.net/people/sunita-pandey/008e5bb8-0eb3-45d8-8524-734ac0454250)

Company: https://www.globalkeysolutions.net/companies/lemaitre-vascular-inc/b7461758-e3aa-4103-8d51-58c729f0c3cd

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7