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  5. One Chang Corp. - 481154 - 11/05/2018
  1. Warning Letters

CLOSEOUT LETTER

One Chang Corp. MARCS-CMS 481154 —

Product:
Food & Beverages
Recipient:
Recipient Name
Mr. Yang Zhou Lu
Recipient Title
President and Owner
One Chang Corp.

839 40th Street
Brooklyn, NY 11232-3803
United States

Issuing Office:
Office of Human and Animal Food Operations East – Division 1

United States

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-2016-2 dated November 10, 2015. 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.

Sincerely,
/S/
CDR Catherine Beer
Director, Compliance Branch
Office of Human and Animal Food Operations East – Division 1

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