Tri-Med, Inc. dba Advanced Care Infusion-Shelby

CLOSEOUT LETTER Tri-Med, Inc. dba Advanced Care Infusion-Shelby MARCS-CMS 478092 — May 02, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Tri-Med, Inc. dba Advanced Care Infusion-Shelby United States Issuing Office: United States Division of Pharmaceutical Quality Operations III 300 River Place, Suite 5900 Detroit, MI 48207 Telephone: (313) 393-8100 Fax: (313) 393-8139 May 2, 2018 UPS NEXT DAY SIGNATURE REQUIRED Dr. William C. Drake, PharmD President Tri-Med, Inc. dba Advanced Care Infusion-Shelby 39011 Harper Avenue Clinton Township, MI 48036 Dear Dr. Drake: 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-DET-04 dated December 18, 2015. 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 Director of Compliance Division of Pharmaceutical Quality Operations III Content current as of: 05/07/2018