DynaFlex – FDA 483, Mar 6, 2026

Ortho Solutions LC, dba DynaFlex, a manufacturer of Class II medical devices in Lake Saint Louis, MO, received an FDA Form 483 with six observations. The inspection revealed significant quality system deficiencies, including failures in medical device reporting, unique device identification, equipment calibration, control of non-conforming products, complaint investigations, and process validation. These issues indicate a broad lack of adherence to regulatory requirements and internal procedures.