FDA 483 - Nippon Fine Chemical Co., Ltd.

Nippon Fine Chemical Co., Ltd., an API Intermediate manufacturer in Takasago City, Japan, received a Form 483 for deficiencies in its quality system and facilities. The inspection revealed inadequate investigations into rejected lots for foreign matter and a lack of proper exhaust ventilation systems in packaging operations, leading to visible dust accumulation. These observations highlight concerns regarding product quality and environmental control.