Delivery Method: VIA Electronic Mail Product: Drugs Recipient:
Recipient Name
Mark W. Shinabery
Recipient Title
Owner and Pharmacist-In-Charge
Custom Compounding Center
11700 Kanis Rd
Suite 1
Little Rock, AR 72211
United States
Mark@customccrx.com Issuing Office: Office of Pharmaceutical Quality Operations, Division II
United States
Mr. Shinabery:
The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter 2016-DAL-WL-14, dated March 16, 2016. We acknowledge that your firm no longer produces sterile drug products. Based on our evaluation, it appears that you have adequately addressed the violations contained in this warning letter.
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,
/S/
CDR John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II
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Content current as of:
11/05/2020
