FDA 483 - Sato Pharmaceutical Co., Ltd. - November 21, 2025

The FDA conducted an inspection of Sato Pharmaceutical Co., Ltd., an OTC drug manufacturer in Hachioji, Tokyo, from November 13 to November 21, 2025. The inspection revealed significant compliance issues, particularly in the firm's aseptic processing and contamination control measures. Key observations included the firm's failure to thoroughly investigate and address media fill failures, which were linked to bacterial contamination by organisms such as Bacillus cereus and various foreign particles like polyester and rayon fibers. Despite renovations to the aseptic line, these issues persisted, indicating inadequate corrective and preventive actions.

Additionally, the firm's procedures to prevent microbiological contamination in sterile drug products were found lacking. Specifically, airflow visualization studies did not adequately validate the aseptic process, as the smoke used in these studies failed to demonstrate uniform airflow or the absence of turbulence, critical for maintaining sterile conditions.

Under the regulatory framework, Sato Pharmaceutical is required to conduct a comprehensive investigation to identify root causes of contamination, implement effective corrective and preventive actions, and ensure proper validation of aseptic processes. The firm must address these deficiencies promptly to comply with FDA standards and ensure the safety and efficacy of its products for the U.S. market.