Tris Pharma Inc.

CLOSEOUT LETTER Tris Pharma Inc. MARCS-CMS 534537 — December 27, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: Via Email Delivery Confirmation Product: Drugs Recipient: Recipient Name Mr. Ketan Mehta Recipient Title President and CEO Tris Pharma Inc. 2033 US Highway 130 Suie D Monmouth Junction , NJ 08852 United States Issuing Office: New Jersey District Office United States Dear Mr. Mehta: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (CMS # 534537) dated March 26, 2018. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter. 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. Respectfully, /S/ Diana Amador-Toro Program Division Director/District Director U.S. Food and Drug Administration OPQO Division I / New Jersey District Content current as of: 01/14/2022 Regulated Product(s) Drugs