FDA 483 - Asahi Kasei Finechem Co., Ltd. - November 10, 2025

This FDA Form 483 was issued to Asahi Kasei Finechem Co., Ltd. (Nobeoka Plant, Japan) following an inspection conducted from November 10 to November 14, 2025. The inspection identified a significant deficiency in the company"s quality control practices related to product release testing for the U.S. market. The primary observation noted that the firm failed to ensure the accuracy and reliability of its analytical methods. Specifically, Asahi Kasei Finechem Co., Ltd. did not perform required validation studies for several in-house developed test methods, including those for Heavy Metals, E. coli, and Salmonella Species. Furthermore, the company also neglected to conduct verification studies for U.S. Pharmacopeia (USP) methods used for finished product release, such as Loss on Drying (LOO) and Identification (IR) tests. This lack of validated and verified analytical methods compromises the company"s ability to demonstrate that its test results accurately reflect product quality and compliance with established specifications. To address this, Asahi Kasei Finechem Co., Ltd. is expected to implement corrective actions to validate all in-house analytical methods and verify all USP methods used for drug product release testing for the U.S. market, ensuring they meet proper standards of accuracy and reliability. The regulatory framework underpinning these observations emphasizes the critical importance of robust quality control and analytical testing in pharmaceutical manufacturing.