FDA 483 - Cetylite Industries, Inc. - December 20, 2019

An FDA inspection of Cetylite Industries, Inc. in Pennsauken, NJ, a pharmaceutical manufacturer, revealed significant deficiencies in quality management and product control. The firm was cited for inadequate qualified personnel in its Quality Assurance and Quality Control units, leading to uncompleted manufacturing process validations and overdue Annual Product Reviews. Additionally, the quality and safety of the compressed gas propellant used in their aerosol topical anesthetic spray were unknown, and the product lacked an approved marketing application.