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Talk to a SpecialistTalk to a SpecialistEurosirel S.P.A, an Italian pharmaceutical manufacturer, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of finished drug products, including topical formulations and pain patches. The company failed to conduct required identity testing for drug components, particularly glycerin—a high-risk ingredient prone to contamination with diethylene glycol and ethylene glycol—and did not validate the reliability of supplier test analyses at appropriate intervals as mandated by 21 CFR 211.84(d). These deficiencies rendered the company's drug products adulterated under the Federal Food, Drug, and Cosmetic Act, with violations identified during an FDA inspection conducted May 20-24, 2024.