FDA 483 - Respire Medical Holdings, LLC - August 15, 2019

The FDA inspected Respire Medical Holdings, LLC, an oral appliance manufacturer, and identified significant deficiencies across its quality system. The firm failed to adequately address medical device reporting, complaint investigations, design validation, process validation, and control of nonconforming products. Additionally, issues were noted in corrective and preventive actions, equipment maintenance, and incoming product acceptance, indicating a lack of robust controls for device quality and safety.