FDA 483 - Taiho Pharmaceutical Co., Ltd. - January 26, 2024

During an FDA inspection conducted from January 22-26, 2024, at Taiho Pharmaceutical Co., Ltd., a bulk drug manufacturer located in Itano-Gun, Tokushima, Japan, several significant observations were made. These observations indicate deviations from quality standards governing drug manufacturing.

A key issue identified within the Facilities and Equipment System was the failure to routinely inspect and maintain automatic and mechanical equipment according to a written program designed to ensure proper performance. Specifically, inspectors found that corroded manufacturing tooling, initially noted with defects in 2017 and worsening by 2019, was continuously used until 2021. This occurred without a documented thorough investigation, remediation, or evaluation of its potential impact on drug products, affecting multiple bulk lots of specific tablet strengths.

Furthermore, deficiencies were noted in the Laboratory System. The firm lacked scientifically sound and appropriate sampling plans to verify that components and drug products conformed to required standards of identity, strength, quality, and purity. An example cited was the absence of growth promotion testing for each shipment of microbial media. Instead, subsequent shipments of the same media lot were released based on initial shipment testing results, without adequate scientific justification.

Taiho Pharmaceutical Co., Ltd. is expected to address these observations by thoroughly investigating the root causes, implementing comprehensive corrective actions, and demonstrating sustainable compliance with quality system requirements to safeguard the quality and integrity of its drug products.