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LeMaitre Vascular, Inc. was cited for manufacturing Artegraft Collagen Vascular Grafts in violation of Quality System Regulation (21 CFR Part 820) requirements. FDA investigators found during a March-April 2025 inspection at the company's North Brunswick, NJ facility that the firm failed to establish and maintain procedures to prevent equipment and product contamination, including deficiencies in USP water sampling procedures for testing conductivity, Total Organic Carbon (TOC), endotoxin, and microbial contamination. The devices were determined to be adulterated due to nonconformity with current good manufacturing practices for manufacture, packing, storage, and installation.