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ARJ Infusion Services Inc MARCS-CMS 548673 —

Delivery Method:

Recipient Name
Mary L. Sackuvich
Recipient Title
President and Owner
ARJ Infusion Services Inc
ARJ Infusion Services Inc

7930 Marshall Drive
Lenexa, KS 66214
United States

Issuing Office:
Center for Drug Evaluation and Research

United States

Dear Ms. Sackuvich:

The U.S. Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our warning letter (ref: Case# 548673) dated April 2, 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 assure 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
Compliance Director
Division of Pharmaceutical Quality Operations III

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