At the end of the inspection, a Form 483 was issued with one observation which is procedural in nature, it added.
Published Date – 03:52 PM, Wed – 20 September 23
New Delhi: 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.
“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
