FDA 483 - Phillips Precision, Inc. - July 17, 2024

Phillips Precision, Inc. received a Form 483 citing significant deficiencies in its quality system, particularly concerning process validation for cleaning implantable devices and surgical instruments. The firm failed to adequately validate cleaning processes, monitor critical process parameters, and establish effective corrective and preventive actions. Additionally, issues were noted in the control of nonconforming product, acceptance activities, equipment maintenance, contamination prevention, and employee training.