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Home » LeMaitre Vascular Gets Extensive Form 483 for CAPA, Sterilization Issues
LeMaitre Vascular Gets Extensive Form 483 for CAPA, Sterilization Issues
Burlington, Mass.- based LeMaitre Vascular drew a lengthy Form 483 from the FDA for failing to follow the company’s own corrective and preventive action (CAPA) procedure and to control nonconforming product, among other lapses.