FDA 483 - Apnar Pharma LLP - May 14, 2021

An FDA inspection of AUREX LABORATORIES LLC in East Windsor, NJ, a pharmaceutical manufacturer, revealed significant deficiencies in their written procedures and adherence to quality control responsibilities. Observations included inadequate cleaning and maintenance procedures, failure to follow quality control unit protocols for environmental monitoring and equipment maintenance, and insufficient detail in component sampling procedures. These findings indicate a need for improved procedural documentation and compliance within the firm's manufacturing operations.