FDA 483 - Fukuzyu Pharmaceutical Co., Ltd. - November 11, 2025

During an inspection conducted by the U.S. Food & Drug Administration from November 5-11, 2025, Fukuzyu Pharmaceutical Co., Ltd., an active pharmaceutical ingredient manufacturer in Toyama, Japan, received a Form FDA 483 detailing significant observations. The inspection revealed critical deficiencies primarily in equipment cleaning practices and quality system controls.

Specifically, the FDA noted a failure to properly clean equipment, resulting in potential cross-contamination risks. Inspectors observed rust-like substances and residues on non-dedicated manufacturing equipment used for various drug substances. One instance involved equipment with a complex design that the company failed to include as a critical component in its cleaning procedures, despite it being a product-contact surface. This observation regarding inadequate cleaning was a repeat finding.

Furthermore, the Quality Unit exhibited a lack of control over important documentation. The inspection found that loose forms used for recording Good Manufacturing Practice (GMP) activities, such as stability testing and equipment cleaning, could be issued multiple times without proper tracking or reconciliation. This uncontrolled issuance compromised the integrity and traceability of critical quality and production records.

Fukuzyu Pharmaceutical Co., Ltd. is expected to address these observations by implementing comprehensive corrective and preventive actions to ensure compliance with regulatory standards for manufacturing active pharmaceutical ingredients.