Lupin receives FDA establishment inspection report for Pithampur Unit-2

Global pharmaceutical corporation, Lupin Limited has received the Establishment Inspection Report (EIR) from the US Food and Drug Administration (FDA) for its Pithampur Unit-2 facility in Madhya Pradesh.

This manufacturing unit, which produces oral solids and ophthalmic dosage forms, underwent its last inspection from March 21 to March 29, 2023. The US FDA classified the facility as “Voluntary Action Indicated” (VAI).

The EIR serves as the FDA’s formal communication that it has completed an inspection of a facility that manufactures FDA-regulated products. This report provides the company with the opportunity to address any observations made during the inspection before the final FDA determination is made.

In this case, the VAI classification implies that although minor objectionable conditions or practices were found, the FDA will not take or recommend regulatory or enforcement action because they do not justify such action.

This announcement follows a period of intense scrutiny and regulatory oversight for Lupin, as the company strives to meet global manufacturing standards. Receipt of the EIR for its Pithampur Unit-2 facility from the FDA indicates progress in Lupin’s ongoing efforts to enhance compliance and quality across its manufacturing operations.