Lupin gets 2 observations from USFDA
Drug firm Lupin on Saturday said it has received two observations from the US health regulator following the inspection of its Nagpur manufacturing facility.
A PAI (Prior Approval Inspection) was carried out by the United States Food and Drug Administration (USFDA) at the company’s Nagpur oral solid dosage manufacturing facility between January 6-10, 2020, Lupin said in a filing to BSE.
Also read: Inspection procedure by FDA regulatory
“The inspection closed with two 483 observations,” Lupin said.
The USFDA issues observations by means of Form 483 notifying a company’s management of objectionable conditions at the facility inspected.
“We are committed to meeting the highest quality standards and are committed to full compliance with CGMP regulations at all our manufacturing facilities.
The Nagpur facility is our latest oral solid dosage facility, and this was the seventh USFDA inspection at the facility,” Lupin MD Nilesh Gupta said.
Lupin will address the observations raised by the agency satisfactorily and will submit a comprehensive response within the stipulated timeline, he added.