FDA WARNING_LETTER - EUROSIREL S.P.A - May 24, 2024

The FDA inspected Eurosirel S.P.A.'s drug manufacturing facility in Cusago, Milan, from May 20-24, 2024, identifying significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). Key deficiencies include the firm's failure to conduct identity testing for each drug component and to validate supplier Certificates of Analysis (COAs) at appropriate intervals, specifically noting inadequate testing of glycerin for hazardous impurities like diethylene glycol (DEG) and ethylene glycol (EG) (21 CFR 211.84(d)(1) and 211.84(d)(2)). Additionally, the firm failed to establish an adequate quality control unit with the necessary authority and oversight for approving or rejecting materials and products (21 CFR 211.22(a)). The FDA recommends engaging a qualified CGMP consultant to evaluate operations, perform a comprehensive six-system audit, and assess corrective actions. The firm must respond within 15 working days detailing corrective actions and prevention plans. Failure to address these violations could lead to FDA withholding new application approvals, re-inspection, and refusal of admission of products into the U.S.