CLOSEOUT LETTER
Lincare, Inc. MARCS-CMS 492840 —
- Recipient:
- Lincare, Inc.
United States
- Issuing Office:
United States
|
|
Office of Pharmaceutical Quality Operations, Division II |
|
|
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