Bell International Laboratories, Inc.

CLOSEOUT LETTER Bell International Laboratories, Inc. MARCS-CMS 669736 — March 04, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 3005574978 Product: Drugs Recipient: Recipient Name Mr. Paul Eichholz Recipient Title Vice President of Quality & Regulatory Compliance Bell International Laboratories, Inc. 2950 Lexington Ave S., Suite 100 Eagan , MN 55121 United States p.eichholz@bellintlabs.com Issuing Office: Division of Pharmaceutical Quality Operations III United States Secondary Issuing Offices United States Dear Mr. Eichholz: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter Case #669736 dated February 15, 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/ Rokhsana Safaai-Jazi Compliance Officer Division of Drug Quality II Content current as of: 03/12/2026 Regulated Product(s) Drugs