Indoco Remedies Limited on Wednesday announced the receipt of an Establishment Inspection Report (EIR) with Voluntary Action Indicated (VAI status from the US Food and Drug Administration (USFDA) for their facility for solid dosages (Plant I) located in Verna, Goa, through an exchange filing.
The recent inspection held from January 16, 2023, to January 20, 2023, was a surveillance inspection.
The receipt of the EIR with VAI status also signifies the imminent closeout of the Warning Letter issued by the USFDA in July 2019 for the manufacturing site, situated at L-14, Verna Industrial Road, Goa (Plant I).
Indoco expects this change in compliance status to pave the way for approvals of ANDAs submitted from this site.
Commenting on this positive development, Ms. Aditi Kare Panandikar, Managing Director – Indoco Remedies Ltd., said, "We are happy to receive the EIR in three and a half months’ time from the date of inspection. It is very encouraging that the site has been endorsed with VAI status, from (Official Action Indicated) OAI status, by the US Regulators.
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 U.S. and around the world."
