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  5. Zhejiang Tianyu Pharmaceutical Co Ltd - 631054 - 02/28/2025
  1. Warning Letters

CLOSEOUT LETTER

Zhejiang Tianyu Pharmaceutical Co Ltd MARCS-CMS 631054 —

Reference #:
FEI 3010972581
Product:
Drugs
Recipient:
Recipient Name
Mr. Tu Yongjun
Recipient Title
President and Founder
Zhejiang Tianyu Pharmaceutical Co Ltd

Jiangkou Development Zone
Huangyan Qu
Taizhou Shi
Zhejiang Sheng, 318020
China

Issuing Office:
Center for Drug Evaluation and Research (CDER)

United States

Secondary Issuing Offices

United States

Dear Mr. Youngjun:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-22-23 dated August 17, 2022.

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 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 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/
Sai S. Dharmaraj
Compliance Officer
Division of Drug Quality I

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