U.S. drug regulator issues Form 483 with 6 observations
U.S. drug regulator issues Form 483 with 6 observations
The U.S. Food and Drug Administration (U.S. FDA) has issued Aurobindo Pharma Form 483 with six observations following an inspection of one of its manufacturing facilities here.
“The U.S. FDA inspected company’s Unit VII, an oral manufacturing facility situated at Jedcherla, Hyderabad, from May 2-10. At the end of the inspection, we have been issued a Form 483 with six observations,” the drugmaker said in an intimation to the stock exchange on Tuesday.
The company will respond to the U.S. FDA within the stipulated timeline and work closely with the regulator to close the observations, it said. Aurobindo shares closed 1.84% down to ₹603.05 a piece on the BSE.
Form 483 is issued by the U.S. FDA to notify the management of the company, whose facility is inspected, of the objectionable conditions observed by its officials that may constitute violations of the Food Drug and Cosmetic Act and related Acts.
