From USFDA
Dr Reddy Laboratories has received the Established Inspection Report (EIR) from the USFDA for its manufacturing facility at Duvvada, Vishakhapatnam, Andhra Pradesh.In the cover letter to the EIR, the UDFDA has explained that the inspection has not closed and the site's status remain unchanged, but the FDA has released the EIR in order to be transparent about its regulatory process.
The Company is planning to request a re-inspection in 2018 after further discussion on scheduling with FDA.
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