Dr. Reddy's Lab gets EIR for formulations facility in Visakhapatnam

18 Feb 2019 Evaluate

Dr. Reddy's Laboratories has received Establishment Inspection Report (EIR) from the US Food and Drug Administration (USFDA) for FTO VII, the company’s formulations manufacturing facility at Duvvada, Visakhapatnam.

This site 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 the company’s 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).

Dr. Reddy’s Laboratories is a multinational pharmaceutical company based in Hyderabad, Telangana in India. It manufactures and markets a wide range of pharmaceuticals in India and overseas.

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