Eurosirel S.P.A

CLOSEOUT LETTER Eurosirel S.P.A MARCS-CMS 690733 — January 26, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Electronic Mail - Return Receipt Requested Reference #: FEI 3015892095 Product: Drugs Recipient: Recipient Name Mr. Matteo Scarpis Recipient Title CEO Eurosirel S.P.A Viale Europa 30 20047 Cusago MI Italy matteo.scarpis@eurosirel.it Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States Dear Mr. Scarpis: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-25-17 dated November 20, 2024. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections. This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The FDA expects you and your firm to maintain compliance and will continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, /S/ Daniel W. Brisker Compliance Officer Division of Drug Quality II Content current as of: 02/02/2026 Regulated Product(s) Drugs