FDA 483 - Event Medical LTD - May 18, 2022

Event Medical LTD, a medical device manufacturer in Lake Forest, CA, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately establish and implement procedures for corrective and preventive actions, leading to uninvestigated non-conformities and device failures. Additionally, the company's complaint management system was found to be severely lacking, with failures in documenting, evaluating, and timely processing of complaints, including those involving potential device specification failures and patient safety.