FDA 483 - Phoenix Deventures - February 15, 2023

Phoenix Deventures, a medical device manufacturer in Morgan Hill, CA, was inspected by the FDA from February 3-15, 2023. The inspection revealed significant deficiencies across multiple quality system areas, including management review, material control, equipment calibration, complaint handling, CAPA documentation, supplier controls, and non-conforming product management. These issues indicate a systemic lack of adherence to established procedures and regulatory requirements.