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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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El-Gen LLC - Close Out Letter 4/9/13

  

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

 
 New York District
Food & Drug Administration
158-15 Liberty Avenue
Jamaica, NY 11433

 

April 9, 2013


Mr. Roy McKeen, President
Il-Gen LLC
138 Haven Ave Ste 101
Port Washington, NY 11050


Dear Mr. McKeen:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to Warning Letter NYK-2012-22 issued to you on September 13, 2012. Based on our evaluation of your written responses and follow-up inspection, 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 will 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/

LCDR Kristen C. Jackson
Compliance Officer
New York District