FDA 483 - Nippon Fine Chemical Co., Ltd. - November 14, 2025

During an inspection conducted by the U.S. Food and Drug Administration (FDA) from November 10 to 14, 2025, Nippon Fine Chemical Co., Ltd., an API Intermediate Manufacturer located in Takasago City, Hyogo, Japan, received a Form FDA 483. This document outlined two significant inspectional observations related to the company's quality system and facility infrastructure.

The first observation highlighted deficiencies in the quality system, specifically regarding the investigation process for product deviations. An investigation into a rejected lot of API intermediate, found to contain foreign matter, was not adequately extended to all potentially associated lots. This led to a subsequent discovery of additional affected batches that also tested positive for foreign matter and were rejected. This indicates a need for more thorough and retrospective investigation protocols.

The second observation pertained to the firm's facilities and equipment. Inspectors noted the absence of adequate local exhaust ventilation systems in the packaging rooms where API intermediates and excipients are handled. This deficiency resulted in visible accumulation of powder material on surfaces within these areas, posing potential risks of cross-contamination and inadequate environmental control.

Nippon Fine Chemical Co., Ltd. is required to address these observations by implementing robust corrective and preventive actions to ensure compliance with quality and operational standards for pharmaceutical manufacturing.