FDA 483 - Respire Medical Holdings, LLC - October 25, 2022

Respire Medical Holdings, LLC, a manufacturer of sleep apnea devices in Brooklyn, NY, was cited for significant quality system deficiencies during an FDA inspection. Observations included failure to submit an MDR report for an allergic reaction, inadequate design verification, and poor supplier selection and control. Further issues involved undocumented personnel training, lack of device master record maintenance with expired raw materials, and inadequate document control procedures, indicating a broad lack of control over critical manufacturing and quality processes.