- Apotex Pharmachem India Pvt Ltd.
10903 New Hampshire Avenue
Silver Spring, MD 20993
December 20, 2016
Jeremy B. Desai, Ph.D.
President and Chief Operating Officer
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
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.
Brooke K. Higgins