Aurobindo Pharma Limited has recently informed exchanges that the United States Food and Drug Administration (US FDA) conducted an inspection at Unit-IV of APL Healthcare Limited, a wholly owned subsidiary of the company, located in Naidupeta Mandal, SPSR Nellore district, Andhra Pradesh.
The inspection was carried out from December 8 to December 17, 2025. At the conclusion of the inspection, the US FDA issued a Form 483 with five observations. The company stated that the observations are procedural in nature and that it will respond to the regulator within the prescribed timelines.
Aurobindo Pharma clarified that the issuance of the Form 483 does not have any impact on the financials or operations of the facility. Manufacturing activities at the unit continue as usual.
The company also reiterated its commitment to maintaining high standards of quality and compliance across all its manufacturing facilities globally and said it will work closely with the US FDA to address the observations.
