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CLOSEOUT LETTER

Essential Pharmacy Compounding MARCS-CMS 489638 —

Delivery Method:
UPS Next Day
SIGNATURE CONFIRMED DELIVERY
Product:
Drugs

Recipient:
Recipient Name
Justin M. Kohll
Recipient Title
Owner
Essential Pharmacy Compounding

12759 Q Street
Omaha, NE 68137
United States

Issuing Office:
Center for Drug Evaluation and Research

300 River Place
Suite 5900
Detroit, MI 48207
United States

(313) 393-8100

Dear Mr. Kohll,

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter dated March 10, 2016 (Case #489638), which was issued under your firm’s former name, Essential Pharmacy Compounding. 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/
Nicholas F. Lyons
Director Compliance Branch
Division of Pharmaceutical Quality Operations III