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Dear Ho Dong Yang:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter # 2575. Based on our evaluation, it appears that you have addressed the violations contained in the warning letter and corrected the data discrepancies between labeling and electronic listing files, thus this warning letter is closed. Future FDA 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. If this product is reintroduced in U.S. commercial distribution, FDA expects that all previous errors are corrected. 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/
Tina Smith
Acting Director, Office of Unapproved Drugs & Labeling Compliance
Center for Drug Evaluation and Research
Office of Compliance
U.S. Food and Drug Administration