The US FDA in its communication mentioned it may withhold approval of any pending applications or supplements in which this facility is listed.
This is the second US FDA GMP inspection of this facility within one year
The USFDA had classified Strides Puducherry facility as OAI in May 2019 followed by issuing a warning letter to this site in July 2019.
Based on this inspection and the USFDA VAI classification, this facility is in compliance with regard to current good manufacturing practices (cGMP)
Government of India has granted a patent for invention entitled "An improved safe process for the preparation of Sartan drugs of Formula I".
The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI)
Department and Industry Associations to organize 3 days National Level Expo on Indian Medical Devices Sector at Pragati Maidan, New Delhi between 9-11 Dec 2022, first of its kind expo in India
The OAI classification implies that the USFDA expects further corrective actions and may withhold approval of any pending product applications or supplements filed from this facility till the outstanding observations are resolved
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