Exela Pharma Sciences LLC

CLOSEOUT LETTER Exela Pharma Sciences LLC MARCS-CMS 611316 — April 30, 2021 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: VIA Electronic Mail Product: Drugs Recipient: Recipient Name Phanesh Koneru, Ph.D., LL.M. Recipient Title President & CEO Exela Pharma Sciences LLC 1245 Blowing Rock Blvd. Lenoir , NC 28645 United States Issuing Office: Office of Pharmaceutical Quality Operations, Division II United States Dear Dr. Koneru: The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter [Case #: 611316; Date: April 8, 2021]. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter. We acknowledge your firm’s intent to discontinue your 503B program, as stated in your warning letter response. You are expected to take all necessary steps to ensure compliance with the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means. Sincerely, Digitally signed by Dayna I. Martinez -S DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, 0.9.2342.19200300.100.1.1=2000369349, cn=Dayna I. Martinez -S Date: 2021.04.30 12:20:09 -04'00' Dayna Martinez Acting Director, Compliance Branch Office of Pharmaceutical Quality Operations, Division II Content current as of: 02/11/2022 Regulated Product(s) Drugs