FDA 483 - Osmotica Pharmaceutical US LLC - January 18, 2019

Osmotica Pharmaceutical Corp in Marietta, GA, was inspected by the FDA from January 15-18, 2019. The inspection revealed a significant issue with the firm's GMP training program, specifically the failure to conduct annual training for employees. This observation is a repeat finding from a previous FDA-483 issued in 2013, indicating a persistent problem.