FDA 483 - Taisho Pharmaceutical Co., Ltd. - March 25, 2019

An inspection of Taisho Pharmaceutical Co., Ltd. in Saitama, Japan, revealed significant deficiencies across its operations. The firm was cited for inadequate laboratory and production controls, including issues with data integrity, validation, and system security. Additionally, batch production and control records were found to be incomplete, and written calibration procedures for instruments and temperature monitoring were deficient.