FDA 483 - MPS Pharma & Medical Inc. - February 13, 2026

MPS Pharma & Medical Inc. in Brea, CA, was inspected by the FDA, resulting in two observations regarding its medical device manufacturing. The inspection revealed significant deficiencies in the firm's risk management processes, including inadequate identification of hazards for both sterilization and internal processes. Additionally, the firm failed to adequately maintain design and development files for its Luer Lock Transfer Pin, lacking critical documentation such as design reviews, inputs, and planning.