Bioiberica, SAU

CLOSEOUT LETTER Bioiberica, SAU MARCS-CMS 629115 — January 15, 2025 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 1000418405 Product: Drugs Recipient: Recipient Name Mr. Luis Solera Blasco Recipient Title Chief Executive Officer Bioiberica, SAU Carrer Antic Cami de Tordera 109-119 08389 Palafolls Barcelona Spain Issuing Office: Center for Drug Evaluation and Research (CDER) United States Secondary Issuing Offices United States Dear Mr. Luis Solera Blasco: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-22-20 dated June 30, 2022. Based on our evaluation, it appears that you have addressed the deviations 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 deviations be observed during a subsequent inspection or through other means. Sincerely, /S/ Rokhsana Safaai-Jazi Compliance Officer Division of Drug Quality II Content current as of: 01/29/2025 Regulated Product(s) Drugs