Apotex Research Private Limited - Close Out Letter 12/20/16
- Apotex Research Private Limited
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 320-15-06
Location: Plot #1 and #2, Bommasandra Ind. Area
4th Phase, Jigani Link Rd., Jigani Hobli
Dear Dr. Desai:
The Food and Drug Administration has completed an evaluation of Apotex Research Pvt. Ltd. (FEI 3006076314), corrective actions in response to our Warning Letter 320-15-06, dated January 30, 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.
Brooke K. Higgins
Division of Drug Quality I