FDA 483 - Respironics California, LLC - September 10, 2021

An FDA inspection of Respironics California, LLC in Carlsbad, CA, revealed significant deficiencies in their quality system. The firm failed to adequately establish design validation procedures for its Class II V60 Ventilator, including shipping devices with statistically invalid verification testing. Furthermore, the company did not properly investigate numerous complaints concerning V60/V60 Plus Ventilator backup batteries, neglecting to retrieve them for necessary root cause analysis.