FDA 483 - Cetylite Industries, Inc. - March 02, 2023

Cetylite Industries, Inc. in Pennsauken, NJ, was inspected and cited for significant deficiencies across its manufacturing and quality control systems. The inspection revealed failures in thoroughly investigating discrepancies, inadequate laboratory controls including testing methods and component identification, and insufficient cleaning validation for equipment. Additionally, the firm failed to conduct microbiology analysis for drug products and exhibited poor control over quality unit procedures and material handling.