The US Food and Drug Administration (USFDA) has issued Form-483 with two observations for Lupin’s Nagpur oral solid dosage facility. This form is issued to a firm’s management if violations of the Food Drug and Cosmetic (FD&C) Act and related Acts are found. It notifies the company’s management of objectionable conditions found during the inspection. Lupin has stated that it is confident of addressing the observations raised and will work with the FDA to resolve them at the earliest.

The US agency inspected the Nagpur facility from July 3 to July 11, 2023. Earlier in the week, Lupin announced that it had received an Establishment Inspection Report (EIR) from the US health regulator for its Pithampur Unit-2 facility. The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI). This signifies that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.

Lupin’s Managing Director, Nilesh Gupta, sees the EIR as a significant milestone in rebuilding the company’s reputation for quality and compliance. He looks forward to new product approvals and launches, especially ophthalmic products from the Nagpur facility. Lupin is committed to being best-in-class in terms of quality and compliance.

For more details, read the full article on The Economic Times website.