FDA 483 - Fuji Yakuhin Co., Ltd. - November 25, 2022

This FDA Form 483 was issued to Fuji Yakuhin Co., Ltd., a sterile drug manufacturer located at 682, Itakura, Fuchu-Machi, Toyama-Shi, Toyama, 939-2721 Japan. The inspection was conducted by Investigator Robert J. Martin from November 17, 2022, to November 25, 2022. The report was issued to Takuya Moto, Division Director, Production Division.

Three observations were noted:

1. **Procedures to prevent microbiological contamination of sterile drug products are not established, written, and followed.** * **Aseptic Manufacturing (Building 1, Filling Line 1):** Operators' actions during a simulation run (November 17, 2022) and actual manufacturing of [b(4)] Injection (November 25, 2022, observed via security camera) were insufficient. Deficiencies included: * Operators' movements were not slow and deliberate. * Failure to sanitize the interior of [b(4)] each time it was opened. * Operators' hands hanging below their waist. * Failure to fully remove settle plate covers. * Spraying [b(4)] on hands and sleeves prior to personnel monitoring. * Insufficient finger sampling (not rolling to