USFDA sends EIR to Aurobindo Pharma formulation unit

20 Dec 2023 , 03:02 PM

The U.S. Food and Drug Administration (FDA) issued a Form 483 with three observations following an inspection of the formulation manufacturing facility (Unit III) of drugmaker Aurobindo Pharma in Hyderabad in July. The FDA has since received an establishment inspection report from the regulator.

The unit was inspected by the U.S. FDA from July 14–21. It is situated in Bachupally village, Medchal Malkajgiri district, Telangana. In a filing on Thursday, Aurobindo Pharma stated, ‘The unit has now received an EIR classifying the facility as Voluntary Action Indicated (VAI).’

The company stated that the observations were procedural in nature after filing Form 483, that it would reply to the U.S. FDA within the allotted time frames, and that it would collaborate closely with the regulator to close the observations as soon as possible. 

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