FDA EIR - Respironics California Inc - May 19, 2022

Respironics California, LLC, a medical device manufacturer in Carlsbad, California, was subject to an FDA compliance follow-up inspection from April 25 to May 19, 2022. The inspection, conducted under medical device regulatory guidelines, focused on open Class I recalls and V60 ventilator products. The FDA issued an FDA-483 document detailing two primary objectionable conditions. Firstly, the company's procedures for corrective and preventive action (CAPA) were found to be inadequately established. This included multiple overdue action items within critical CAPAs, such as those related to 35V power supply failures and ventilator alarming issues. Previous CAPAs were also identified as ineffective, with failures to thoroughly investigate root causes and address recurring quality problems like airflow accuracy. The firm also lacked consistent analysis of service record data to proactively identify nonconforming products. Secondly, document control procedures were not adequately established, with observed instances where changes were not sufficiently reviewed for accuracy before implementation. Management acknowledged the findings and committed to providing a written response to the FDA-483, outlining their proposed corrective actions, consistent with agency requirements following such inspections.