FDA 483 - NIPPON Meka Co., Ltd. - October 04, 2025

The FDA conducted an inspection of Nippon Meka Co., Ltd., an API manufacturer located in Ashikaga, Tochigi, Japan, from September 24 to October 4, 2025. The inspection revealed several critical compliance issues. Firstly, the company failed to verify that the test procedures used in stability testing were stability-indicating, impacting at least five APIs. This lack of method verification contravenes the firm's standard operating procedures (SOP Q-54-13) for U.S. marketed products.

Additionally, the firm demonstrated inadequate control over quality control samples, lacking processes for sample management, chain of custody, and traceability. This resulted in incorrect and irreconcilable sample records, particularly for batch-16 in 2025, where samples from different batches were mixed, compromising sample integrity.

Further observations included the failure to review laboratory control records adequately. The firm relied on paper printouts without proper review of electronic data, which is critical for ensuring the identity and purity of APIs. Moreover, the company did not establish adequate processes to ensure APIs meet quality specifications, with issues noted in electronic data management and backup procedures.

The FDA requires Nippon Meka Co., Ltd. to address these violations by validating stability test methods, implementing robust sample management processes, ensuring thorough review of laboratory records, and establishing comprehensive data management systems. These actions are necessary to comply with FDA regulations and ensure the quality and safety of products intended for the U.S. market.