Aurobindo Pharma has received an Establishment Inspection Report (EIR) from the US health regulator for its manufacturing facility at Pydibhimavaram in Andhra Pradesh.

The company's Unit XI at Pydibhimavaram is an API non-antibiotic manufacturing facility. It was inspected by the US Food and Drug Administration (USFDA) in February 2019 and issued a warning letter in June 2019. It was inspected further by the USFDA from July 25 to August 2, 2022, and issued a Form 483 with three observations. Form 483 is issued to a firm's management after 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.

As per the USFDA, VAI classification is given when objectionable conditions were found and documented during the inspection but the agency is not prepared to take or recommend regulatory action.