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  5. Tri-Med, Inc. dba Advanced Care Infusion-Shelby - Close Out Letter 5/2/18
  1. Warning Letters

CLOSEOUT LETTER

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


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


United States

Issuing Office:

United States


 

  

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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