- Delivery Method:
- VIA Electronic Mail
Recipient NamePhanesh Koneru, Ph.D., LL.M.
Recipient TitlePresident & CEO
- Exela Pharma Sciences LLC
1245 Blowing Rock Blvd.
Lenoir, NC 28645
- Issuing Office:
- Office of Pharmaceutical Quality Operations, Division II
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'
Acting Director, Compliance Branch
Office of Pharmaceutical Quality Operations, Division II