FDA 483 - Toyobo Co. Ltd. - July 30, 2019

Toyobo Co. Ltd. in Otsu, Shiga, Japan, a sterile drug manufacturer, was cited for significant deficiencies during an FDA inspection. Observations included a lack of written procedures for production and process controls, inadequate quality control unit procedures for CAPA effectiveness, insufficient controls over computer systems for analytical data, and inadequate validation of aseptic processes to prevent microbial contamination. These issues indicate a broad failure to ensure drug product quality, purity, and sterility.