FDA 483 - Bard Shannon Limited - November 21, 2018

BARD SHANNON LIMITED, a medical device manufacturer in Humacao, PR, was cited with eight observations during an FDA inspection from October 22 to November 21, 2018. The inspection revealed significant deficiencies across its quality system, particularly concerning corrective and preventive actions, production process controls, validation procedures, environmental controls, acceptance activities, equipment maintenance, and device history records. These issues indicate a systemic failure to adhere to established procedures and ensure product quality and safety.