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

An FDA inspection of Nippon Shikizai, Inc. in Tsukuba, Japan, an OTC drug manufacturer, revealed significant deficiencies in their quality systems. Observations included inadequate cleaning validation for manufacturing equipment, insufficient calibration and verification of production scales, and a lack of written procedures for tracking and managing deviations by the quality assurance unit. These issues indicate a need for improved controls to ensure drug product quality and compliance.