FDA 483 - Nissan Chemical Corporation - November 21, 2025

This FDA Form 483 document outlines critical observations made during an inspection of a pharmaceutical manufacturing facility, conducted by the U.S. Food and Drug Administration (FDA) from November 17 to November 21, 2025. The primary concern identified during the inspection, issued to Mr. Furuyashiki Nobuyoshi, Deputy Plant Manager, was the inadequacy of the firm's stability studies for an Active Pharmaceutical Ingredient (API). Specifically, the stability studies failed to sufficiently support the labeled retest date for the API. A significant deficiency noted was the absence of microbial testing within these studies, which is crucial for assessing the risk of microbial contamination throughout the API's entire shelf life or retest period. The report also indicated that batches of this API had been distributed to the U.S. market within the last three years, dating back to November 2022. While the 483 form details inspectional observations, it mandates that the firm evaluate these findings and implement necessary corrective actions to ensure compliance with regulatory standards. A formal response detailing the firm's plans or completed actions to address these deficiencies is expected by the FDA.