FDA 483 - Curexa - East, LLC dba Curexa - September 09, 2022

An FDA inspection of Curexa - East, LLC dba Curexa in Egg Harbor Township, NJ, revealed significant deficiencies in manufacturing practices. Observations included widespread non-microbial contamination in production areas, inadequate cleaning procedures for hazardous drug production leading to potential cross-contamination, and the release of drug products with inconsistent fill heights, impacting quality. These issues indicate a lack of control over the manufacturing environment and product quality.