FDA 483 - Respironics California, LLC - January 10, 2020

Respironics California, LLC, a medical device manufacturer in Carlsbad, CA, was cited for significant quality system deficiencies during an FDA inspection. The firm failed to adequately establish procedures for corrective and preventive actions, leading to unaddressed issues with ventilators that resulted in patient deaths and serious injuries. Additionally, the inspection revealed late Medical Device Reports, inadequate control of nonconforming product, and failures in complaint handling and incoming product acceptance procedures.