Delivery Method: VIA Electronic Mail Product: Drugs


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.

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