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  5. Tai Heng Industry Co., Ltd. - 03/27/2017
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Tai Heng Industry Co., Ltd.

Tai Heng Industry Co., Ltd.

United States

Issuing Office:

United States



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10903 New Hampshire Avenue
Silver Spring, MD 20993 

March 27, 2017

Jim Fang, Managing Director
Tai Heng Industry Co., Ltd.
Room 116, 2 Qiming Dalou
Shanghai Juke Biotech Park
Shanghai, 200231 China

Reference: FEI 3006986091

Dear Mr. Fang:

The Food and Drug Administration has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-16-11 dated May 12, 2016. Based on our evaluation, it appears that you have addressed the violations contained in this W aming 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.

Kevin Maguire
Compliance Officer
Division of Drug Quality II

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