Aurobindo has received further Form 483 observations from the US Food and Drug Administration for two of its manufacturing facilities. Four observations for each facility were received after FDA investigators inspected the firm’s Unit V active pharmaceutical ingredient manufacturing facility at Pashamylaram, Hyderabad from 21-28 October 2019, and its Unit VIII, API manufacturing facility at Gaddapotharam, Hyderabad of the Company from 21-25 October 2019. Meanwhile, an inspection at Aurobindo’s Unit IV formulation manufacturing facility at Pashamylaram is in progress.
“We believe that these observations are related to procedural improvements and none of the observations are related to data integrity,”...
