Aurobindo Pharma was issued a Form 483 with six observations by the United States Food and Drug Administration (USFDA) following an inspection of one of its manufacturing facilities in Hyderabad.
“The US Food and Drug Administration (FDA) inspected the Company’s Unit VII, an oral drug manufacturing facility in Jedcherla, Hyderabad, May 2-10. At the end of the inspection, we received a Form 483 with six observations,” the drugmaker said in a statement to the exchange on Tuesday.
The company will respond to the US FDA within the specified timeframe and will work closely with the regulator to complete the observations, it said. Aurobindo shares closed up 1.84% at ₹603.05 apiece.
Form 483 is issued by the U.S. FDA to notify management of the company whose facility is being inspected of objectionable conditions observed by its officials that may constitute a violation of the Food Drug and Cosmetic Act and related statutes.