Aurobindo Pharma Gets 5 USFDA Observations for Unit-IV Facility
New Delhi: Aurobindo Pharma Limited has announced that the United States drug regulator has classified Unit-IV of its wholly owned subsidiary APL Healthcare Limited as "Voluntary Action Indicated" (VAI) following a regulatory inspection, indicating the closure of the inspection process.
According to the company, the facility located at Palchur village and part of Palepalem village in Naidupeta Mandal of SPSR Nellore district, Andhra Pradesh, was inspected by the U.S. Food and Drug Administration between December 8 and December 17, 2025. At the conclusion of the inspection, the regulator issued a Form 483 containing five observations.
The company stated that the facility has now received the Establishment Inspection Report (EIR) from the USFDA, which classifies the inspection outcome as “Voluntary Action Indicated.” With the issuance of the EIR, the inspection has been officially closed.
The update was shared with stock exchanges under Regulation 30 of the SEBI (Listing Obligations and Disclosure Requirements) Regulations, 2015. The company had earlier informed the exchanges about the inspection through its communication dated December 18, 2025.
