FDA 483 - Dispo-Med (Malaysia) Sdn Bhd - June 15, 2023

An FDA inspection of Dispo-Med (Malaysia) Sdn Bhd, a medical device manufacturer, was conducted from June 12-15, 2023, resulting in a Form FDA 483 listing four key observations related to deficiencies in their quality management system. The company's procedures for Corrective and Preventive Actions (CAPAs) were found inadequate, specifically lacking documented investigations for root causes and corrective actions for recurring nasal prong component rejections.

Design Change procedures were also deficient. A filter modification for a patient monitoring system was implemented without technical justification or verification testing. Furthermore, a material change for nasal prongs lacked proper documentation, approval, and a required risk assessment. Procedures for accepting incoming products were not adequately established, as Certificates of Conformity from suppliers failed to confirm essential blockage testing for Airway Adapters, despite prior commitments.

Lastly, production processes for the nasal prong CO2 cannula product were not properly controlled. The dipping process lacked adequate control over temperature and timing, and relevant devices were uncalibrated. An on-site observation revealed dipping times outside specified ranges, and the Operational Qualification did not establish an acceptable process parameter range.

These observations underscore the need for Dispo-Med to enhance its quality system to ensure product specifications are consistently met. The firm has committed to addressing these issues within six months.