FDA 483 - Artegraft, Inc. - April 16, 2025

LeMaitre Vascular, Inc. in North Brunswick, NJ, was inspected and received a Form FDA 483 with eight observations. The inspection revealed significant deficiencies across multiple quality system areas, including contamination control, environmental monitoring, equipment maintenance, process validation, bioburden monitoring, corrective and preventive actions, device history records, and employee training. These issues indicate a systemic lack of adherence to established procedures and regulatory requirements for medical device manufacturing.