- Delivery Method:
- VIA Electronic Mail
Recipient NameMark W. Shinabery
Recipient TitleOwner and Pharmacist-In-Charge
- Custom Compounding Center
11700 Kanis Rd
Little Rock, AR 72211
- Issuing Office:
- Office of Pharmaceutical Quality Operations, Division II
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.
CDR John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,