FDA 483 - Alps Pharmaceutical Industrial Co., Ltd. - April 05, 2019

Alps Pharmaceutical Ind. Co. Ltd, an API manufacturer in Hida, Gifu, Japan, was cited for multiple quality system deficiencies during an FDA inspection. Observations included failures in equipment cleaning, inadequate cleaning procedures, lack of studies on product contact surfaces, insufficient stability data for API retest dates, and incomplete investigations into product discrepancies and complaints. These issues indicate a need for improved quality control and adherence to manufacturing standards.