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

LeMaitre Vascular, Inc. in North Brunswick, NJ, was inspected and received a Form FDA 483 with 8 observations. The inspection revealed significant deficiencies across multiple quality system areas, including inadequate procedures for contamination prevention, environmental monitoring, equipment maintenance, process validation, CAPA management, device history records, and employee training. These issues indicate a systemic lack of control over critical manufacturing processes for their medical devices, particularly the Artegraft Collagen Vascular Graft.