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  5. Dongying Tiandong Pharmaceutical Co Ltd - 506849 - 01/11/2019
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CLOSEOUT LETTER

Dongying Tiandong Pharmaceutical Co Ltd MARCS-CMS 506849 —

Recipient:
Recipient Name
Dr. Lei Dong
Recipient Title
General Manager
Dongying Tiandong Pharmaceutical Co Ltd
Dongying Tiandong Pharmaceutical Co Ltd

No. 1236 Nan-er Road
Dongying Qu
Dongying Shi
Shandong Sheng, 257067
China

Issuing Office:
Center for Drug Evaluation and Research

United States

Dear Mr. Dong:

The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-17-06 dated November 10, 2016. Based on our evaluation, it appears that you have addressed the deviations contained in this Warning Letter. Future FDA inspections and regulatory activities will further assess the adequacy and sustainability or these corrections.

This letter does not relieve you or your firm from the responsibility or 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 FDA 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 deviations be observed during a subsequent inspection or through other means.

Sincerely,
/S/
Rokhsana Jazi
Compliance Officer
Division of Drug Quality II

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