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

An FDA inspection of P.T. Sankei Medical Industries, a medical device manufacturer, was conducted from May 8-11, 2023, in Serang, Banten, Indonesia. The inspection resulted in eight observations detailed on a Form FDA-483, indicating significant deficiencies in the company's quality management system, consistent with the FDA's Quality System Regulation. Key issues included a lack of established procedures for design control, specifically for Single Patient Use Sphygmomanometer Units that had been shipped since 2019 without proper design process adherence. The firm also had inadequate procedures for corrective and preventive actions (CAPA), failing to analyze quality data for root causes and trend analysis. Further observations noted incomplete purchasing procedures that did not require supplier evaluations based on quality. Device history records were found insufficient to demonstrate manufacturing in accordance with device master records, which themselves were not adequately maintained. Critical shortcomings were identified in complaint handling, as procedures did not ensure complaints were evaluated for potential Medical Device Reporting (MDR) events. Additionally, written MDR procedures were undeveloped, lacking internal systems for timely identification, evaluation, transmission, and record-keeping of adverse events. Finally, quality audit procedures were insufficient, without documented evidence of scheduled quality system audits. P.T. Sankei Medical Industries committed to correcting all observed deficiencies.