ARJ Infusion Services Inc

CLOSEOUT LETTER ARJ Infusion Services Inc MARCS-CMS 548673 — March 06, 2019 More Warning Letters Warning Letters About Warning and Close-Out Letters Delivery Method: UPS Recipient: 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. Sincerely, /S/ Nicholas F. Lyons Compliance Director Division of Pharmaceutical Quality Operations III Content current as of: 03/12/2019