FDA 483 - Nippon Shikizai, Inc. - August 06, 2019

An FDA inspection of Nippon Shikizai, Inc. in Tsukuba, Ibaraki, Japan, an OTC drug manufacturer, revealed significant deficiencies. Observations included inadequate cleaning validation for multi-product equipment, insufficient calibration of production scales, and a lack of written procedures for tracking and managing deviations by the quality assurance unit. These issues indicate potential risks to drug product quality and compliance with cGMP regulations.