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CLOSEOUT LETTER

Sandoz Private Limited Jun 08, 2017

Sandoz Private Limited - Close Out Letter 6/8/17


Sandoz Private Limited

 

  

Black HHS-Blue FDA Logo

 

 

 
10903 New Hampshire Avenue
Silver Spring, MD 20993 

June 8, 2017

Mr. Richard Francis
Division Head
Sandoz International GmbH
Industriestrasse 25
83607 Holzkirchen
Germany

Reference: Warning Letter 320-16-01

Location:

Sandoz Private Limited (Kalwe facility)
MIDC Plot Nos. 8-A/2 & 8-B
TTC Industrial Area, Kalwe Block
Village Dinghe, Navi Mumbai 400 708
Maharashtra, India
 

Sandoz Private Limited (Turbhe facility)
Plot Nos. 031 & D32, MIDC,
TTC Industrial Area, Turbhe
Thane-Belapur Road, Navi Mumbai 400 705
Maharashtra, India

Dear Mr. Francis:

The Food and Drug Administration has completed an evaluation of Sandoz Private Limited (FEI 3004944629) and Sandoz Private Limited (FEI 3003737804) corrective actions in response to our Warning Letter 320-16-01, dated October 22, 2015. 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