Ajanta Pharma Receives USFDA EIR for Paithan Plant, Inspection Closed with VAI Status
New Delhi: Ajanta Pharma Limited has announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (USFDA) for its Paithan manufacturing facility in Maharashtra, with the inspection being classified as Voluntary Action Indicated (VAI).
The company disclosed the development through an intimation submitted to the National Stock Exchange of India Limited (NSE) and BSE Limited on July 2, 2026, informing investors about the receipt of the Establishment Inspection Report following the completion of the USFDA inspection at the facility.
According to the filing, the current Good Manufacturing Practices (cGMP) inspection of the company's Paithan manufacturing facility was conducted by the USFDA from April 13, 2026, to April 21, 2026.
Ajanta Pharma stated that it had previously informed the stock exchanges about the USFDA inspection through an earlier disclosure dated April 22, 2026. The latest filing confirms that the company has now received the Establishment Inspection Report (EIR) and that the inspection has been classified as Voluntary Action Indicated (VAI).
A Voluntary Action Indicated (VAI) classification indicates that while the USFDA identified certain objectionable conditions during the inspection, the observations do not warrant regulatory or administrative action at this stage, and any corrective measures are expected to be undertaken voluntarily by the company.
According to the Ajanta Pharma regulatory filing, the company has received the USFDA Establishment Inspection Report for its Paithan, Maharashtra, manufacturing facility following the cGMP inspection conducted between April 13 and April 21, 2026. The inspection has been classified as Voluntary Action Indicated (VAI), and the company has informed the stock exchanges that the update is being shared for the information of investors.
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