Manufacturing woes continue for Aurobindo after FDA's warning letter
An active pharmaceutical ingredient site in India has been handed a warning letter from the FDA, following an August 2021 inspection.
AuroLife Pharma’s Hyderabad site, which is part of the Aurobindo group of companies, was handed the letter in November. It’s the latest in a string of manufacturing woes the company has battled as of late.
Unit 1 of its Hyderabad site was inspected, and received an official action initiated notice from the FDA. “The company believes that this will not impact the existing business from this facility,” it said in a filing.
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