FDA 483 - Dynalabs LLC - September 26, 2019

DynaLabs LLC, a control testing laboratory in Saint Louis, MO, was cited for significant deficiencies in its quality control and laboratory operations. The inspection revealed that test methods for drug products lacked proper validation for customer-specific formulations, and the stability program was inadequate. Furthermore, deviations from procedures were not consistently recorded or justified, and the Quality Unit was found to be deficient in its responsibilities.