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Aurobindo Pharma on Wednesday said the US health regulator has issued a Form 483 with one observation after inspecting a formulation production facility of its unit in Andhra Pradesh. The US Food and Drug Administration (US FDA) inspected the Unit IV of APL Healthcare Ltd, a wholly-owned subsidiary of the company, in Tirupati district of Andhra Pradesh from September 13-19, 2023, the Hyderabad-based drug major said in a regulatory filing.
At the end of the inspection, a Form 483 was issued with one observation which is procedural in nature, it added.
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“We will respond to the US FDA within the stipulated timelines and work closely with US FDA to close the observation at the earliest,” Aurobindo Pharma stated.
As per the USFDA a Form 483 is issued to a firm’s management at the conclusion of an inspection when the investigator has observed any conditions that may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. Shares of Aurobindo Pharma were trading 0.63 per cent down at Rs 889.15 apiece on the BSE.
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