Aurobindo Pharma announced that the company's Unit XI, an API Non-antibiotic manufacturing facility situated at Pydibhimavaram, Srikakulam District, Andhra Pradesh was inspected by the United States Food and Drug Administration (USFDA) in February 2019 and issued a warning letter in June 2019 and this Unit was further inspected by USFDA from 25 July to 2 August 2022 and issued a Form 483 with 3 observations.
Subsequent to the company's responses for the aforesaid observations, the company has received an Establishment Inspection Report (EIR) classifying the inspection as Voluntary Action Indicated (VAI) from the US FDA and with this, the inspection at the Unit XI is concluded.
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