Pharmaceutical major Aurobindo Pharma has received an Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its Unit III in the Bachupally Village, Telangana.
The US drug regulator classified the aforementioned unit as Voluntary Action Indicated (VAI), the company announced in an exchange on September 7. The EIR report indicates the closure of the inspection.
The US FDA conducted an inspection at Aurobindo Pharma Limited, Bachupally Village, Telangana from July 14-21.
On July 21, the US FDA issued a Form 483 containing three observations for the mentioned unit.
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