Last Updated on December 31, 2023 by The Health Master
Hyderabad: The United States Food & Drug Administration (USFDA) has issued a Form 483 with three observations to Hyderabad-based pharma major Aurobindo Pharma’s formulations manufacturing facility in Hyderabad.
Aurobindo’s Unit III, which is located at Bachupally in Medchal Malkajgiri district, was inspected by USFDA from July 14 to 21 this year.
The company informed the bourses that the observations are procedural in nature and it would keep the stock exchanges if there was any material information relating to the matter in future.
“We will respond to the USFDA within the stipulated timelines and work closely with USFDA to close the observations at the earliest,” Aurobindo Pharma said in a regulatory filing.
The latest development comes close on the heels of the company’s Unit XIV, located at Jawaharlal Nehru Pharma city in Parawada mandal of Anakapalli district of Andhra Pradesh, receiving EIR (establishment inspection report) earlier this week.
The EIR was issued by USFDA after it inspected the unit from May 15 to 19 this year.
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