FDA 483 - Respironics California, LLC - May 19, 2022

Respironics California, LLC, a medical device manufacturer in Carlsbad, CA, was cited for significant deficiencies in its quality system. The inspection revealed inadequate corrective and preventive action (CAPA) procedures, leading to overdue actions and ineffective resolutions for issues related to Class I recalled ventilators. Additionally, the firm failed to adequately establish document control procedures, resulting in the release of a design specification with an incorrect flow sensor value for the V8000 ventilator.