USFDA has conducted inspection at Lupin's Dabhasa facility from 29th June to 6th July 2016. At the end of the inspection two 483s were issued. Both the observations are minor in nature and corrective and preventive actions were shown to the inspectors during the inspection. The inspection has been classified as Voluntary Action Indicated (VAI).
Lupin is a transnational company engaged in development of APIs, generic and branded formulations. It is the largest manufacturer of Tuberculosis drugs in the world having onshore and offshore presence of its products in 70 countries. Its manufacturing unit is located in Goa, Tarapur, Ankleshwar, Jammu, Mandideep, Indore, Aurangabad and Kyowa in Japan.
