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Dr Reddy’s Laboratories has informed that it has received a written communication from the United States Food and Drug Administration (USFDA), about the issuance of Establishment Inspection Report (EIR) for FTO VII, the formulations manufacturing facility at Duvvada, Visakhapatnam.
This site of the Hyderabad based pharma major was included in the warning letter received from 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 informed the Bombay Stock Exchange (BSE).
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