The company has received an EIR with Voluntary Action Indicated (VAI) status from USFDAfor its facility for solid dosages (Plant I) located in Verna, Goa, Indoco Remedies said in aregulatory filing. As per USFDA, a VAI means that objectionable conditions or practices werefound, but the agency is not prepared to take or recommend any administrative or regulatory action.

New Delhi: Drug firm Indoco Remedies on Wednesday saidit has received an Establishment Inspection Report (EIR) from the US health regulator for its Goa-based plant. The US Food and Drug Administration (USFDA) gives EIR on closure of inspection of an establishment.

The company has received an EIR with Voluntary Action Indicated (VAI) status from USFDA for its facility for solid dosages (Plant I) located inVerna, Goa, Indoco Remedies said in a regulatory filing.

As per USFDA, a VAI means that objectionable conditions or practiceswere found, but the agency is not prepared to take or recommend anyadministrative or regulatory action. The inspection held from January 16-20, 2023, was a surveillance inspection, the drug maker said.

"The receipt of the EIR with VAI status also signifies the imminentcloseout of the warning letter issued by USFDA in July 2019 for themanufacturing site," it added.

The company said it expects this change in compliance status to pavethe way for approvals of abbreviated new drug applications (ANDAs)submitted from this site.

"We are committed to maintaining strict adherence to the highestquality standards and to ensuring delivery of safe and effective genericmedicines to our patients in the US and around the world," IndocoRemedies Managing Director Aditi Kare Panandikar noted. Shares of thecompany were trading 1.9 per cent up at Rs 327.55 apiece on the BSE.