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On Wednesday, Aurobindo Pharma has said that it has received a Form 483 with six observations from United States Food and Drug Administration (US FDA) for its Unit-III formulation facility located at Bachupally in Hyderabad.
The plant has been inspected by US FDA from April 10-18.
Aurobindo has said in a statement to stock exchanges that all the observations are related to procedural improvements, “None of the observations are related to data integrity.”
It has further said that “The company will be responding as per the prescribed time lines.”
