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Aurobindo Pharma on Thursday said the US health regulator has issued a Form 483 with five observations after inspecting Andhra Pradesh-based Unit-IV of its subsidiary APL Healthcare.
The US Food and Drug Administration (USFDA) inspected the unit from December 8 to December 17, 2025, the Hyderabad-based drug firm said in a regulatory filing.
"At the end of the inspection, a 'Form 483' was issued with 5 observations which are procedural in nature, and we will respond to the US FDA within the stipulated timelines," it added.
The company is committed to maintaining the highest quality manufacturing standards at all of its facilities across the globe, the drug firm said.
As per the US Food and Drug Administration (USFDA), 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 0.83 per cent up at Rs 1,203 apiece on BSE.
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