USFDA completes inspection of Lupin's Nagpur facility, no adverse observations

Homegrown pharma major Lupin Ltd on Thursday said the US health regulator has completed inspection at its Nagpur oral solid manufacturing facility.

The inspection by the the US Food and Drug Administration (USFDA) for facility at Nagpur was carried out between August 5, 2019 and August 8, 2019. It closed without any 483 observations, Lupin said in a statement.

Commenting on the outcome of the inspection, Lupin Managing Director Nilesh Gupta said, "We are committed to adherence and full compliance with cGMP (current good manufacturing practice) regulations at all our manufacturing sites".

He further said, "The Nagpur facility is our latest oral solid dosage facility and this was the sixth USFDA inspection at the facility. We are very happy that the inspection closed with no 483s".

As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when investigator has observed any condition that in its judgement may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.