- Divi's Laboratories Ltd. (Unit II)
- Issuing Office:
10903 New Hampshire Avenue
Silver Spring, MD 20993
November 7, 2017
Mr. Kiran Divi
Director and President Operations
Divi's Laboratories Ltd. (Unit 11)
Chippada Village, Annavararn
Andhra Pradesh, 531163 India
Reference: FEI 3004149463
Dear Mr. Divi:
The Food and Drug Administration (FDA) has completed an evaluation of your firm's corrective actions in response to our Warning Letter: 320-17-34 dated April 13, 2017. Based on our evaluation, it appears that you have addressed the 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 pertain to CDER/OPQ, CDER/OND, or CDER/OGD decision-making on any pending applications naming this facility and is without prejudice to future decisions by those offices relating to such applications.
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 deviations be observed during a subsequent inspection or through other means.
Division of Drug Quality II