FDA 483 - ITL Asia Pacific Sdn Bhd - May 30, 2019

ITL Asia Pacific Sdn Bhd, a medical device manufacturer in Batu Gajah, Malaysia, was inspected and cited for significant quality system deficiencies. The inspection revealed failures in establishing and following procedures for design control, corrective and preventive actions, process validation, device history records, complaint handling, medical device reporting, and quality audits. These issues indicate a systemic lack of control over critical manufacturing and quality processes for their SampLok Luer Kit and SampLok System with Hinged Lid.