FDA 483 - CPAPNEA Medical Supply - July 30, 2019

CPAPNEA MEDICAL SUPPLY, a medical device manufacturer in Phoenix, AZ, was inspected by the FDA. The inspection revealed a severe lack of fundamental quality system procedures, with nine observations citing the absence of established processes for critical activities such as corrective and preventive actions, complaint handling, design control, and device history records. This indicates a systemic failure to implement basic regulatory requirements for medical device manufacturing.