FDA 483 - Curexa - East, LLC dba Curexa - September 09, 2022
Discuss this record with AI
Document or profile
One record shows the event. A profile shows the pattern.
Buy this document for the source file and details behind this single event.
Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.
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.
ID · 8fc76674-284a-4e67-a014-2db69ecd6178