"We have received a written communication from the USFDA, about the issuance of EIR for FTO VII, our formulations manufacturing facility at Duvvada, Visakhapatnam," the company said in a press note.
This site was included in the warning letter received from the USFDA in November 2015.
Subsequently, the site was audited by USFDA in March 2017 for which the company received EIR in November 2017, wherein the site's status remained unchanged. The site was again audited in October 2018.
"Based on our responses and follow up actions, the USFDA has concluded that this inspection is closed and has determined the inspection classification of this facility as Voluntary Action Initiated (VAi)," the company added.