Issues Form 483 with five observations
Aurobindo Pharma announced that the United States Food and Drug Administration (US FDA) inspected Unit-IV of APL Healthcare, a wholly owned subsidiary of the Company, situated at Palchur village and part of Palepalem Village Naidupeta Mandal, SPSR Nellore District, 524126, Andhra Pradesh, from 08 December to 17 December 2025.At the end of the current inspection, a Form 483' was issued with 05 observations which are procedural in nature, and we will respond to the US FDA within the stipulated timelines.
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