FDA 483 - Outin Futures Corp - August 12, 2022

Outin Futures Corp., a manufacturer in Chungju, Korea, was cited for multiple significant deficiencies in its manufacturing practices for OTC drug products. The inspection revealed severe issues across training, stability studies, laboratory controls, in-process material management, equipment cleaning, and process validation, with several repeat observations indicating a systemic lack of adherence to cGMP regulations.