FDA 483 - NIPRO CANADA CORPORATION - May 31, 2018

An FDA inspection of Cardiomed Supplies, Inc., a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately validate critical processes like pouch sealing and Ethylene Oxide sterilization, and lacked proper procedures for corrective and preventive actions and design validation. Additionally, their risk analysis was incomplete, failing to address known hazards with kit components.