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  5. Henan Lihua Pharmaceutical Co., Ltd. - 548089 - 08/12/2021
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CLOSEOUT LETTER

Henan Lihua Pharmaceutical Co., Ltd. MARCS-CMS 548089 —

Reference #:
FEI 3001164052
Product:
Drugs

Recipient:
Recipient Name
Mr. Nui Zhigang
Recipient Title
General Manager
Henan Lihua Pharmaceutical Co., Ltd.

Middle of Huanghe Street
Anyang Shi
Henan Sheng, 455000
China

Issuing Office:
Center for Drug Evaluation and Research | CDER

United States


Dear Mr. Zhigang:

The food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter 320-18-58 dated June 12, 2018.

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/
Kevin Maguire
Compliance Officer
Division of Drug Quality II
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research, FDA

 

 

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