Inspections, Compliance, Enforcement, and Criminal Investigations

Divi's Laboratories Ltd. (Unit II) - Close Out Letter 11/7/17

 

  

Black HHS-Blue FDA Logo

 

 

 
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
Bheemunipatnarn Mandal
Visakhapatnarn District
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.

Sincerely,
/S/

Marisa Heayn
Compliance Officer
Division of Drug Quality II

Page Last Updated: 11/09/2017
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