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CLOSEOUT LETTER

Yandi New York Trading Co Ltd


Yandi New York Trading Co Ltd

  

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

October 13, 2015


Mr. Liu Hu, President
Yandi New York Trading Co Ltd
129b 48th Street
Brooklyn, NY 11232-4227


Dear Mr. Lu:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter NYK-2015-12 issued on November 21, 2014. Based on our evaluation, it appears that you have addressed the violation(s) 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.

Please send your reply to the Food and Drug Administration, 158-15 Liberty Avenue, Jamaica, NY 11433, Attention: LCDR Kristen C. Jackson. If you have questions regarding any issues in this letter, please contact LCDR Jackson at 718-662-5711.


Sincerely,

/S/

Kristen C. Jackson
Compliance Officer
New York District