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  1. Compliance Actions and Activities

CLOSEOUT LETTER

Option Care Apr 12, 2018

Option Care - Close Out 4/12/18


Recipient:
Option Care


United States

Issuing Office:

United States


 

  

Black HHS-Blue FDA Logo

 

 

 
Office of Pharmaceutical Quality Operations, Division 2
4040 North Central Expressway, Suite 300
Dallas, TX 75204-3158 

April 12, 2018

John C. Rademacher, Chief Executive Officer
Option Care, Inc.
3000 Lakeside Drive, Suite 300N
Bannockburn, Illinois 60015

Dear Mr. Rademacher:

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: 2017-DAL-WL-01] issued on October 19, 2016, following our inspection of your facility, Option Care, Inc., located at 14220 Northbrook Drive, Suite 100B, San Antonio, Texas 78232, from July 20, 2015 to August 6, 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.

If you have any questions regarding this letter, please contact me at 214-253-5288 or via email at John.Diehl@fda.hhs.gov.

Sincerely,
/S/

LCDR John W. Diehl, M.S.
Director, Compliance Branch
Office of Pharmaceutical Quality Operations,
Division II

 

cc:
Mary Lozano
Director of Operations
Option Care, Inc.
14220 Northbrook Drive, Suite 100B
San Antonio, Texas 78232