New Delhi: Leading drug firm Aurobindo Pharma on Wednesday said it has got an establishment inspection report from the US health regulator with voluntary action indicated (VAI) status for its Unit-IV facility in Pashamylaram of Hyderabad.
The firm did not disclose the details of the US FDA report in its regulatory filing.
The United States Food and Drug Administration (USFDA) had in November 2019 issued a Form 483 with 14 observations after the inspection of its Unit-IV, according to a 13 November regulatory filing by the pharma company.
Form 483 is issued to management of a company to conclude an inspection when an investigator observes conditions that may be in violation of US FDA regulations under its Food Drug and Cosmetic (FD&C) Act and related Acts, according to the US regulator’s definition available on the website.
“The company has received the establishment inspection report (EIR) with VAI status from USFDA,” Aurobindo Pharma said in a regulatory filing.