Institute of Good Manufacturing Practices India®

Lupin receives two observations from USFDA for Nagpur facility


Lupin, a drug firm on Saturday stated that it has obtained two observations from the US health regulator following the inspection of its Nagpur manufacturing facility.

A PAI (Prior Approval Inspection) was conducted by the United States Food and Drug Administration (USFDA) at the Nagpur oral solid dosage manufacturing facility of company between January 6-10, 2020.

Lupin stated that the auditing was closed with two 483 findings.
The USFDA furnishes observations by means of Form 483 notifying a management of company regarding objectionable conditions at the facility inspected.

Lupin MD Nilesh Gupta of Lupin stated that they are focused on meeting the highest quality standards and are committed to full compliance with regulations of CGMP at all their manufacturing facilities. The Nagpur facility is their latest oral solid dosage facility, and this was the seventh USFDA inspection at the facility.

Lupin will respond to the observations rose by the agency satisfactorily and will file a comprehensive response within the stipulated timeline, he further added.