FDA 483 - ST JUDE COSTA RICA LTDA. - February 27, 2020

ST JUDE COSTA RICA LTDA., a medical device manufacturer in El Coyol, Alajuela, was cited for significant deficiencies in process validation during an FDA inspection. The firm failed to adequately validate processes for its Portico valves, including a lack of proper validation, insufficient documentation, and non-adherence to established procedures. These issues indicate a breakdown in the firm's quality system regarding critical manufacturing processes and data integrity.