FDA 483 - Chongqing Daxin Pharmaceutical Co., Ltd. - June 28, 2024

An FDA inspection of Chongqing Daxin Pharmaceutical Co., Ltd. in Chongqing, China, was conducted from June 24-28, 2024. The U.S. Food and Drug Administration issued a Form FDA 483, highlighting two critical observations indicating deviations from established good manufacturing practices for Active Pharmaceutical Ingredients (APIs).

Firstly, inspectors noted that written procedures for cleaning equipment used in API manufacturing were not followed. Specifically, equipment labeled "Cleaned," including tanks and reactors, was found to have visible material residue and cotton-like threads. This lapse in sanitation practices raises concerns about potential cross-contamination and product quality.

Secondly, the facility lacked adequate environmental controls, as there were no instruments to monitor the temperature in rooms designated for API packaging processes. Monitoring these conditions is crucial, as specific temperature requirements are essential for maintaining the stability and integrity of finished APIs. The absence of such monitoring poses a risk to product quality and efficacy.

Chongqing Daxin Pharmaceutical Co., Ltd. is now expected to provide a comprehensive response detailing corrective and preventive actions to address these observations and ensure compliance with regulatory standards for pharmaceutical manufacturing.