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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