Drug firm Indoco Remedies on Wednesday said it has received an establishment inspection report from the U.S. health regulator for its Goa-based plant.
The U.S. Food and Drug Administration issues an EIR on the closure of an inspection of an establishment.
The company has received an EIR with Voluntary Action Indicated status from the USFDA for its facility for solid dosages (Plant I) located in Verna, Goa, Indoco Remedies said in a regulatory filing.
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As per 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.
The inspection held from Jan. 16–20, 2023, was a surveillance inspection, the drug maker said.
"The receipt of the EIR with VAI status also signifies the imminent closeout of the warning letter issued by the U.S. FDA in July 2019 for the manufacturing site," it added.
The company said it expects this change in compliance status to pave the way for approvals of abbreviated new drug applications submitted from this site.
"We are committed to maintaining strict adherence to the highest quality standards and to ensuring delivery of safe and effective generic medicines to our patients in the US and around the world," Indoco Remedies managing director Aditi Kare Panandikar noted.
Shares of the company were trading 1.9% higher at Rs 327.55 apiece on the BSE.
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