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  5. Jiangsu NHWA Pharmaceutical Co., Ltd. - 582511 - 11/17/2023
  1. Warning Letters

CLOSEOUT LETTER

Jiangsu NHWA Pharmaceutical Co., Ltd. MARCS-CMS 582511 —

Product:
Drugs

Recipient:
Recipient Name
Weibing Wang
Recipient Title
Vice President – Operations
Jiangsu NHWA Pharmaceutical Co., Ltd.

No. 6 Tianyong Road, Industrial Park
Xuzhou, Jiangsu
221000
China

Issuing Office:
Center for Drug Evaluation and Research | CDER

United States

Secondary Issuing Offices

United States


Dear Mr. Wang:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-19-42 dated September 10, 2019.

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/
Rokhsana Safaai-Jazi
Compliance Officer
Division of Drug Quality II

 
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