FDA 483 - Toyobo Co. Ltd. - January 15, 2018

Toyobo Co., Ltd. Otsu Pharmaceuticals Plant in Otsu-Shi, Japan, was cited for significant deficiencies during an FDA inspection. Observations included widespread data integrity issues in laboratory records and ineffective corrective actions, as well as critical failures in aseptic processing area disinfection and sterilization validation. The firm also lacked adequate procedures for computer software changes and equipment cleanliness inspections.