FDA 483 - P.T. Sankei Medical Industries - May 11, 2023

P.T. Sankei Medical Industries, a medical device manufacturer in Serang, Indonesia, was inspected by the FDA and received eight observations. The inspection revealed significant deficiencies across its quality system, including inadequate procedures for design control, corrective and preventive actions, purchasing, complaint handling, and medical device reporting. The firm also failed to adequately maintain device history and master records and lacked proper quality audit documentation.