DuPont Nutrition USA Inc.

CLOSEOUT LETTER DuPont Nutrition USA Inc. MARCS-CMS 627211 — July 22, 2026 More Warning Letters Warning Letters About Warning and Close-Out Letters Reference #: FEI 3013947845 Product: Drugs Recipient: Recipient Name Mr. Shoba Reddy Chagam Recipient Title Head of Global Regulatory Affairs & Head of Regulatory Affairs Americas DuPont Nutrition USA Inc. Roquette Health and Pharma Solutions BG 1301 Ogletown Road Newark , DE 19711-5419 United States Issuing Office: Division of Pharmaceutical Quality Operations I United States Secondary Issuing Offices United States Dear Mr. Chagam: The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter #627211, dated December 2, 2022. 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/ LaKeesha M. Sifontes Group Supervisor Division of Drug Quality II Content current as of: 07/30/2026 Regulated Product(s) Drugs