FDA 483 - DynaFlex - September 25, 2023

Ortho Solutions LC, dba DynaFlex, a medical device manufacturer in Lake Saint Louis, MO, was cited for significant deficiencies during an FDA inspection. The firm failed to adequately establish procedures for complaint handling, equipment calibration, process revalidation, and supplier management. These issues indicate potential risks to device quality and patient safety, particularly concerning their Class 2 sleep devices.