New Delhi: Dr. Reddy’s Laboratories said it has received an establishment inspection report (EIR) from the US health regulator for its formulation manufacturing facility at Duvvada in Visakhapatnam.
It, however, said the US Food and Drug Administration has not closed the inspection and the manufacturing site’s status remains unchanged.
“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,” Dr. Reddy’s said in a regulatory filing.
It further said: “The USFDA has released the EIR in order to be transparent about its regulatory process. We are planning to request a re-inspection in 2018 after further discussion on scheduling with the USFDA.”
In March this year, Dr. Reddy’s Laboratories had received observations from the US regulator for its Duvvada facility.
The company, however, did not specify the observations.