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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Transonic Systems, Inc. - Close Out Letter 1/16/14

  

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

 

January 16, 2014


Mr. Cornelis J. Drost, President & CEO
Transonic Systems, Inc.
34 Dutch Mill Road
Warren Road Business Park
Ithaca, NY 14850


Dear Mr. Drost:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter, NYK-2013-21, issued on June 19, 2013. 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 ofthese 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 Frank Verni, RPh
Compliance Officer
FDA - New York District