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US FDA withdraws warning letter to Visakhapatnam-based Divi’s Lab


The warning letter was issued in March 2017

US FDA has’closed out’ a warning letter issued to Visakhapatnam-based Divi’s Laboratories. The unit-II of the plant received the alert in March 2017, however, to avoid any shortages in the market, US FDA exempted 10 drugs from the ban.

A letter issued to Divi’s Laboratories on November 7, 2017 by US FDA states, “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.”

The letter also mentions, “This 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.”

The company in a regulatory filing to the BSE states, “Divi’s Laboratories has been informed by the US FDA that the agency has completed evaluation of the company’s corrective actions in response to FDA’s warning letter..dated 13 April 2017. We also note from the update on FDA’s website that they have closed-out the warning letter.”

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