FDA 483 - Pan Medical Ltd. - April 07, 2016

Pan Medical Ltd., a medical device manufacturer in Gloucester, United Kingdom, was cited for significant deficiencies in its quality system. Observations included inadequate process validation for a laser welder, insufficient design validation for a kyphoplasty catheter, incomplete risk analysis, and a lack of procedures and records for equipment maintenance. These issues indicate a systemic failure to ensure product quality and safety.