Premier Nutra Pharma Inc.

CLOSEOUT LETTER Premier Nutra Pharma Inc. MARCS-CMS 640210 — October 11, 2023 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA EMAIL CONFIRMED DELIVERY Product: Drugs Recipient: Recipient Name Israel Kravzov Recipient Title Co-Chief Executive Officer Premier Nutra Pharma Inc. 5800 Newton Drive Carlsbad , CA 92008 United States ikravzov@premiernutrapharma.com Issuing Office: Division of Pharmaceutical Quality Operations IV United States Dear Mr. Kravzov: The U.S. Food and Drug Administration has completed evaluation of your firm’s corrective actions in response to our Warning Letter [Case # 640210; dated December 9, 2022]. Based on our evaluation, it appears that you have adequately 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 agency 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/ CDR Steven E. Porter, Jr. Director, Division of Pharmaceutical Quality Operations IV cc: Hector Gudino Co-Chief Executive Officer Premier Nutra Pharma Inc. hector@premiernutrapharma.com Content current as of: 10/18/2023 Regulated Product(s) Drugs