FDA 483 - Ultra Clean Systems, Inc. - August 11, 2023

An FDA inspection of Ultra Clean Systems, Inc., a medical device manufacturer, conducted from August 7-11, 2023, identified significant deficiencies in its quality management system, as documented in a Form FDA-483. The company was cited for failing to meet regulatory standards across several key areas. These included a lack of established design control procedures, with critical design history records for their Triton 36 and Triton 72 products being unavailable, and risk analyses found incomplete. Design changes were implemented without proper assessment or validation, leading to ongoing product failures. The firm's complaint handling system was deemed inadequate, evidenced by a backlog of nearly 2,000 unresolved complaints, some describing serious issues like 'burnt boards' and 'burning smells,' which had not been properly evaluated or investigated. Corrective and preventive action (CAPA) procedures were also insufficient, failing to analyze quality data for recurring issues or effectively verify corrective actions. Supplier controls were lacking, with critical components purchased without documented evaluation. Furthermore, the software used for complaint handling was not adequately validated, and instances of manual data deletion were observed. Finally, the Medical Device Reporting (MDR) procedure was incomplete, lacking essential elements for timely and proper submission of adverse event reports to the FDA. Ultra Clean Systems, Inc. has committed to addressing these observed deficiencies.