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CLOSEOUT LETTER

Exact-Rx Inc


Exact-Rx Inc

  

Department of Health and Human Services logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration
 Center for Drug Evaluation and Research
Silver Spring, MD 20993-0002 

April 27, 2017

Matt Kornberg
Exact-Rx, Inc.
105 Baylis Road
Melville, NY, 11747
USA

Mr. Kornberg,

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter# 858. Based on our evaluation, it appears that you have addressed the violations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability of these corrections.

This letter does not relieve you or your firm from the responsibility of taking all necessary steps to assure sustained compliance with the Federal Food, Drug, and Cosmetic Act and its implementing regulations or with other relevant legal authority. The Agency expects you and your firm to maintain compliance and to continue to monitor your state of compliance. This letter will not preclude any future regulatory action should violations be observed during a subsequent inspection or through other means.

Sincerely,
/S/

Paul M. Loebach
Director, Drug Registration and Listing Staff
W051, Rm2262
10903 New Hampshire Ave
Silver Spring, MD 20993
301-796-2173
paul.loebach@fda.hhs.gov