Reference #:
3002949085, 3005447965, and 3006549835
Product:
Drugs

Recipient:

Recipient Name

Mr. Satish Reddy

Recipient Title

Chairman

Dr. Reddy’s Laboratories Limited

8-2-337, Road No. 3
Banjara Hills, Hyderabad 530046
Andhra Pradesh
India

Issuing Office:
Division of Drug Quality I

United States


Dear Mr. Reddy:

The Food and Drug Administration (FDA) has completed an evaluation of your firm’s corrective actions in response to our Warning Letter 320-16-02 dated November 5, 2015. Based on our evaluation, it appears that you have addressed the violations and deviations 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 FDA 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 and deviations be observed during a subsequent inspection or through other means.

Sincerely,
/S/
Carrie Ann Plucinski
Compliance Officer
Division of Drug Quality I