FDA 483 - CPAPNEA Medical Supply - October 07, 2020

CPAPNEA Medical Supply, a manufacturer of the Class 1 Optipillows EPAP Mask, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to establish adequate procedures for corrective and preventive actions, device master records, and design controls. These issues indicate a fundamental lack of compliance with medical device quality system requirements.