Lupin gets establishment inspection report from USFDA for Pithampur manufacturing facility

The US Food and Drug Administration FDA issues an EIR on closure of inspection of an establishment that is the subject of an FDA or FDA-contracted scrutiny.The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated VAI.

Drug firm Lupin on Tuesday said it has received an Establishment Inspection Report from the US health regulator for its Pithampur Unit-2 manufacturing facility.

The Establishment Inspection Report (EIR) was issued after the last inspection of the facility, which manufactures oral solids and ophthalmic dosage forms, conducted from March 21-29, 2023, the Mumbai-based drug maker said in a statement. The US Food and Drug Administration (FDA) issues an EIR on closure of inspection of an establishment that is the subject of an FDA or FDA-contracted scrutiny.

The USFDA has determined that the inspection classification of the facility is Voluntary Action Indicated (VAI). According to the the USFDA, a VAI means that objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. ''This is a significant milestone as we build back our reputation of being best-in-class in quality and compliance. We look forward to new product approvals and launches, especially ophthalmic products from this facility now,'' Lupin Managing Director Nilesh Gupta stated.

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