LeMaitre Vascular, Inc. – FDA 483, May 16, 2023

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.