Nippon Kayaku Pharmatech Co., Ltd. – FDA 483, Nov 25, 2020

An FDA inspection of Fuji Yakuhin Co., Ltd., a sterile drug manufacturer located in Toyama-Shi, Japan, was conducted from November 17 to November 25, 2022. This inspection resulted in a Form FDA 483, detailing several significant observations indicating potential deviations from current Good Manufacturing Practices (cGMP) for sterile drug products.

The main issues identified included a failure to establish, write, and follow procedures designed to prevent microbiological contamination. Specifically, investigators observed numerous instances of insufficient aseptic technique by operators during both simulation runs and actual manufacturing processes, such as improper movements, inadequate sanitization, and compromised sterile environments. The firm also failed to demonstrate unidirectional airflow in critical aseptic areas through required studies.

Further observations noted inadequate routine calibration and qualification of automatic, mechanical, and electronic equipment. This included incomplete operational qualification for a stability chamber, lacking recovery and power loss tests, and the absence of re-qualification studies for parts washers and vial sterilizers since their initial installation. Lastly, the company did not retain representative samples of each lot of active pharmaceutical ingredients received for manufacturing. Fuji Yakuhin Co., Ltd. is now required to provide comprehensive corrective actions to address these deficiencies and ensure compliance with regulatory standards.