FDA 483 - Cetylite Industries, Inc. - September 24, 2021

Cetylite Industries, Inc. in Pennsauken, NJ, a pharmaceutical manufacturer, was cited for two significant issues during an FDA inspection. The firm lacked data to support the safety of the propellant used in its Topical Anesthetic Spray and failed to thoroughly investigate out-of-specification results for a Topical Anesthetic Gel batch before release. These observations indicate serious deficiencies in laboratory controls and quality assurance processes.