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Dr.Reddy’s Laboratories has received an establishment inspection report (EIR), for its formulation manufacturing facility at Duvvada in Visakhapatnam, from the US health regulator.
The company has received observations for its Duvvada facility in March this year, but, however it did not specify the observations.
In a regulatory filing Dr.Reddy’s stated, “We have received the establishment inspection report (EIR) from the USFDA for the above mentioned facility. In the cover letter to the EIR, the USFDA has explained that inspection has not closed, and the site’s status remains unchanged.”
It further stated that, the USFDA has released the EIR to be transparent about its regulatory process and Dr.Reddy is planning to request a re-inspection in 2018 after further discussion on scheduling with the USFDA.
