FDA 483 - Sato Pharmaceutical Co., Ltd. - July 03, 2018

Sato Pharmaceutical Company Limited in Hachioji, Tokyo, was cited for significant deficiencies across its drug manufacturing operations. Observations included failures in quality control unit procedures, inadequate environmental monitoring in aseptic processing areas, and a lack of scientifically sound laboratory controls for container closure integrity. Additionally, the firm failed to maintain backup files for critical laboratory data, indicating systemic data integrity concerns.