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  5. Zhucheng Haotian Pharm Co., Ltd. - Close Out Letter 7/12/17
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CLOSEOUT LETTER

Zhucheng Haotian Pharm Co., Ltd. 12/07/2017

Zhucheng Haotian Pharm Co., Ltd. - Close Out Letter 7/12/17


Zhucheng Haotian Pharm Co., Ltd.

 

  

Black HHS-Blue FDA Logo

 

Center for Drug Evaluation and Research
10903 New Hampshire Avenue
Silver Spring, MD 20993-0002

 
 

July 12, 2017

Mr. Wang Lin
Zhucheng Haotian Pharm Co., Ltd.
No. 64 Jiangjun Rd., Xinxing
Zhucheng, Shandong, China 262218
FEI: 3005232754

Dear Mr. Lin:

The Food and Drug Administration has completed an evaluation of your firm’s corrective actions in response to our Warning Letter # 300-12-012 dated June 11, 2012. 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/
Paul Loebach
Director, Drug Registration and Listing Staff
Office of Compliance
Center for Drug Evaluation and Research