FDA 483 - Phoenix Instruments Inc. - May 30, 2025

Phoenix Instruments Inc. in Naperville, IL, was cited with three observations during an FDA inspection. The firm failed to adequately document corrective and preventive actions for nonconforming medical devices and incorrectly assessed CAPA requirements. Additionally, their complaint handling and product recall procedures contained outdated FDA reporting links, a repeat finding, and management did not ensure the quality policy was understood and accessible to employees.