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CLOSEOUT LETTER

Synbiotics Limited


Synbiotics Limited

  

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 4335
Silver Spring, MD 20993

TELEPHONE: (301) 796-4171
             FAX: (301) 847-8742

August 26, 2016

Reference: Warning Letter 320-11-06

Location: Synbiotics Limited
               Plot No 570, 571, 576a, Maitry Marg
               Luna 391440 Gujarat, India
               FEI: 3008494993

Dear Mr. Mohal Sarabhai:

The Food and Drug Administration has completed an evaluation of Synbiotics Limited (FEI 3008494993), corrective actions in response to our Warning Letter 320-11-06, dated December 16, 2010. Based on our evaluation, it appears that you have addressed the violations 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: (301) 796-4171.

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


Sincerely,

/S/

Brooke K. Higgins
Compliance Officer
Division of Drug Quality I