Lincare, Inc.

CLOSEOUT LETTER Lincare, Inc. MARCS-CMS 492840 — March 05, 2018 More Warning Letters Warning Letters About Warning and Close-Out Letters Recipient: Lincare, Inc. United States Issuing Office: United States Office of Pharmaceutical Quality Operations, Division II 4040 N. Central Expressway, Suite 300 Dallas, Texas 75204 March 5, 2018 VIA UPS EXPRESS Gregory McCarthy, CEO Lincare Holdings, Inc. 19387 US 19 N Clearwater, Florida 33764-3102 Dear Mr. McCarthy: 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-DAL-WL-19 dated April 25, 2016. 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. If you have any further questions, you may contact me at (214) 253-5288 . Sincerely, /S/ LCDR John W. Diehl, M.S. Director, Compliance Branch Office of Pharmaceutical Quality Operations, Division II Cc: Chelsey Chandler, Center Manager Lincare, Inc. dba United Medical Home Infusion 1527 S. Bowman Road, Suite D Little Rock, Arkansas 72211-4200 Content current as of: 03/07/2018