U.S. flag An official website of the United States government
  1. Home
  2. Inspections, Compliance, Enforcement, and Criminal Investigations
  3. Compliance Actions and Activities
  4. Warning Letters
  5. Zhejiang Jiuzhou Pharmaceutical Co., Ltd - Close Out Letter 7/5/16
  1. Compliance Actions and Activities

CLOSEOUT LETTER

Zhejiang Jiuzhou Pharmaceutical Co., Ltd Jul 05, 2016

Zhejiang Jiuzhou Pharmaceutical Co., Ltd - Close Out Letter 7/5/16


Zhejiang Jiuzhou Pharmaceutical Co., Ltd

  

Department of Health and Human Services' logoDepartment of Health and Human Services

 
 Food and Drug Administration
Center for Drug Evaluation and Research
Office of Compliance
Office of Manufacturing Quality
Division of Drug Quality I
10903 New Hampshire Avenue
Building #51 , Room 4359
Silver Spring, MD 20993

TELEPHONE: 240-402-1458
            FAX: (301) 847-8742

July 5, 2016

Reference: Warning Letter 320-14-12

Location: Zhejiang Jiuzhou Pharmaceutical Co., Ltd
               No. 99 Waisha Road, Jiaojiang Taizhou,
               Zhejiang Province, 318000 China
               FEI: 3003744377

Dear Ms. Hua Lirong:

The Food and Drug Administration has completed an evaluation of Zhejiang Jiuzhou Pharmaceutical Co., Ltd, FEI: 3003744377 corrective actions in response to our Warning Letter WL: 320-14-12, issued on July 9, 2014. 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.

If you have any questions regarding this letter, you may contact me at the above address or number: (240) 402-1458.

For more information on the U.S. FDA, please visit our website at www.fda.gov.


Sincerely,

/S/

Loan Chin, Pharm.D.
Compliance Officer
Division of Drug Quality I