FDA 483 - Cetylite Industries, Inc. - December 09, 2024

Cetylite Industries, Inc. in Pennsauken, NJ, was cited for significant deficiencies in their manufacturing processes and quality control during an FDA inspection. Observations included inadequate process and cleaning validations, and a failure to thoroughly investigate repeated microbial contamination in their purified water system. These issues indicate a lack of robust controls to assure drug product quality and purity.