USFDA issued Form-483 for Lupin's Nagpur factory with two observations

13 Jul 2023 , 01:46 PM

For Lupin’s Nagpur oral solid dosage plant, the US Food and Drug Administration (USFDA) has issued Form-483 with two observations.

USFDA claims that if there are violations of the Food, Drug, and Cosmetic Act (FD&C) and associated Acts, a firm’s management will receive a Form 483. Management of the company is notified of undesirable conditions via FDA Form 483.

Meanwhile, The medicine company stated in a statement that it is confident in its ability to address the concerns raised and will cooperate with the FDA to address them as soon as possible.

From July 3 to July 11, 2023, the facility was under inspection by a US agency.

The US health department issued an Establishment Inspection Report (EIR) to Mumbai-based Lupin earlier this week for its Pithampur Unit-2 facility, which produces oral solids and ophthalmic dosage forms.

The facility’s inspection classification has been judged by the USFDA to be Voluntary Action Indicated (VAI).

‘This is a key milestone as we restore our image as the finest in our industry for compliance and quality. Since this plant currently produces ophthalmic medications, we anticipate future product approvals and launches, according to Nilesh Gupta, managing director of Lupin, who talked to ET.

On completion of an examination of a business under FDA or FDA-contracted surveillance, the US Food and Drug Administration releases an EIR.

According to the USFDA, a VAI denotes the discovery of undesirable conditions or practises, but the organisation is not yet ready to suggest or take any administrative or regulatory action.

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