FDA 483 - Otsuka Pharmaceutical Co., Ltd. - October 22, 2019

Otsuka Pharmaceutical Co., Ltd. in Naka-Gun, Tokushima, Japan, was inspected and cited for significant deficiencies across its quality system, particularly concerning foreign particle contamination in drug products. The inspection revealed a systemic failure to thoroughly investigate discrepancies, identify root causes for contamination and customer complaints, and maintain adequate control over equipment, documentation, and computer systems. These issues indicate a severe lack of quality oversight impacting the safety, purity, and efficacy of drug products.