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Intercos Europe S.p.A, a drug manufacturing facility in Italy, failed to comply with Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, rendering their OTC sunscreen drug products adulterated. During a March 2024 inspection, the FDA identified critical violations including the firm's failure to adequately test incoming raw materials—specifically glycerin—for identity and safety specifications before use in drug products, and their failure to validate supplier test analyses at appropriate intervals. The firm did not perform required identity testing to detect diethylene glycol (DEG) and ethylene glycol (EG) in glycerin lots, which are necessary to ensure compliance with United States Pharmacopeia safety limits. The company received this warning letter on August 15, 2024, after submitting a response to FDA Form 483 on April 5, 2024.