- Delivery Method:
- UPS Next Day
Recipient NameMark H. Mandel, PharmD
Recipient TitleOwner and Pharmacist-in-Charge
- Snyder Mark Drugs Roselle, Inc. d.b.a. Mark Drugs Pharmacy
384 E. Irving Park Road
Roselle, IL 60172-2007
- Issuing Office:
- Detroit District Office
- (313) 393-8100
Dear Dr. Mandel:
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 # 547409) dated February 27, 2018. 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.
Nicholas F. Lyons
Director of Compliance
Division of Pharmaceutical Quality Operations III