USFDA completes inspection of Nagpur facility with no observations: Lupin

The inspection by the US Food and Drug Administration (USFDA) for a 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.

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

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

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