India, Dec. 18 -- Aurobindo Pharma Ltd has informed that the US Food and Drug Administration (US FDA) conducted an inspection at Unit-IV of APL Healthcare Limited, its wholly owned subsidiary, located in SPSR Nellore district, Andhra Pradesh, from December 8 to December 17, 2025.
Following the inspection, the US FDA issued a Form 483 with five observations, which the company stated are procedural in nature. Aurobindo Pharma said it will submit its response to the regulator within the stipulated timelines.
The company reiterated its commitment to maintaining the highest standards of quality and compliance across all its manufacturing facilities globally. It also clarified that the inspection outcome does not have any impact on the financia...