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

Ultra Clean Systems, Inc. in Oldsmar, FL, was inspected by the FDA from August 7-11, 2023, and received a Form FDA-483 with six observations. The inspection revealed significant deficiencies across multiple quality system areas, including a lack of established design controls, inadequate complaint handling, and insufficient corrective and preventive action procedures. The firm also failed to adequately validate quality system software and maintain a compliant Medical Device Reporting procedure.