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Cetylite Industries, Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in manufacturing finished pharmaceutical drugs, specifically Cetacaine Mint Gel Topical Anesthetic. The company failed to establish appropriate laboratory controls and specifications for testing components and finished products, and improperly used a compendial testing method for aerosol formulations instead of the required method for gel formulations without proper validation. The firm's corrective action response to the FDA's initial inspection findings was deemed inadequate due to insufficient detail and evidence of compliance measures.