USFDA issues 6 observations after inspection of Aurobindo Pharma's Jedcherla facility
"The Company will respond to the USFDA within the stipulated timeline and work closely with USFDA to close the observations," the company added.
Hyderabad: Drugmaker, Aurobindo Pharma, has recently announced that the United States Food and Drug Administration (USFDA) has concluded an inspection with six observations at its Unit VII, an oral manufacturing facility situated at Jedcherla, Hyderabad.
The inspection was conducted from 2nd to 10th May 2022.
"USFDA inspected Company's Unit VII, an oral manufacturing facility situated at Jedcherla, Hyderabad, from 2nd to 10th May 2022. At the end of the inspection, we have been issued a 'Form 483' with six observations," Aurobindo Pharma said in a BSE filing.
Read also: Aurobindo Pharma net profit down 22 percent to Rs 604 crore in Q3
An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.
"The Company will respond to the USFDA within the stipulated timeline and work closely with USFDA to close the observations," the company added.
Read also: Aurobindo Pharma arm bags USFDA nod for cancer drug Bortezomib
