Mumbai, March 07, 2018: Pharma Major, Aurobindo Pharma clarifies on News Items on Company unit 4 getting 9 observation after USFDA inspection Company said in filing with BSE that United States Food and Drug Administration (US FDA) has conducted an inspection at Aurobindo Pharma Ltd’s Unit IV, a formulation manufacturing facility located
at Pashamylaram, Hyderabad from February 12 2018 to February 20 2018.
This is a scheduled inspection and at the end of the inspection, the company was issued a Form 483 with 9 observations none of the observations are related to data integrity or repetitive in nature And company is in the midst of providing a comprehensive response to
the observations and would be replying to the FDA within 15 working days from the date of closure (February 20, 2018) of audit, filing added.
United News of India
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