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. Apotex Pharmachem India Pvt Ltd. - Close Out Letter 12/20/16
  1. Warning Letters

CLOSEOUT LETTER

Apotex Pharmachem India Pvt Ltd.


Apotex Pharmachem India Pvt Ltd.

 

  

Black HHS-Blue FDA Logo

 

 

 
10903 New Hampshire Avenue
Silver Spring, MD 20993 

December 20, 2016

Jeremy B. Desai, Ph.D.
President and Chief Operating Officer
Apotex, Inc.
150 Signet Drive
Toronto, ON, Canada M9L 1 T9

Reference: Warning Letter 320-14-11

Location: Plot #1A, Bommasandra Industrial Area
4th Phase, Jigani Link Rd.
Bangalore, 560 009
India

Dear Dr. Desai:

The Food and Drug Administration has completed an evaluation of Apotex Pharmachem India Pvt. Ltd. (FEI 3005466325), corrective actions in response to our Warning Letter 320-14-11, dated June 16, 2014. 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