FDA 483 - DynaFlex - September 05, 2019

Ortho Solutions LC, DBA DynaFlex, a medical device manufacturer in Saint Ann, MO, was cited for numerous quality system deficiencies during an FDA inspection. The firm failed to submit Medical Device Reports (MDRs) for serious complaints and exhibited widespread issues with design controls, process validation, and device record keeping for their orthodontic and sleep apnea devices. Many of these critical observations were repeats from a previous inspection, indicating persistent non-compliance.