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CLOSEOUT LETTER

Alexander Infusion LLC D/B/A Avanti Health Care May 08, 2017

Alexander Infusion LLC D/B/A Avanti Health Care - Close Out Letter 5/8/17


Alexander Infusion LLC D/B/A Avanti Health Care

 

  

Black HHS-Blue FDA Logo

 

 

 
New York District
158-15 Liberty Ave
Jamaica, NY 11433
 

May 8, 2017

Mr. Pietro Piacquadio, R.Ph.
Chief Executive Officer
Alexander Infusion, LLC, dba Avanti Health Care Services
75 Nassau Terminal Road
New Hyde Park, NY 11040-4927

Dear Mr. Piacquadio:

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: WL# NYK-2015-27), dated March 27, 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/

Ronald Pace
District Director
New York District