Piramal Pharma Closes USFDA Inspection at Lexington Facility with VAI Status
New Delhi: Piramal Pharma Limited has successfully closed the USFDA inspection at its Lexington, Kentucky manufacturing facility following the receipt of an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI) status, marking completion of the regulatory review process.
The company informed that the United States Food and Drug Administration (USFDA) issued the EIR for the facility, confirming the closure of the inspection that had been previously initiated and disclosed in December 2025.
The VAI classification indicates that while certain observations may have been noted during the inspection, they do not warrant regulatory enforcement action, allowing the facility to continue operations.
Piramal Pharma stated that the receipt of the EIR represents a successful conclusion of the inspection process for its Lexington-based manufacturing site in the United States.
The Lexington facility is an important part of Piramal Pharma’s global manufacturing network, supporting its presence in regulated markets including the United States.
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