Wednesday, 25 April 2018

Audit report: Dr Reddy's gets EIR from USFDA for UK plant

Dr Reddy's Laboratoriestoday said it has received an establishment inspection report (EIR) from the US health regulator
after audit of its UK facility. "With regard to the audit of our API Mirfield plant, United Kingdom, we would now like to inform you that we have received an establishment inspection report (EIR) from the USFDA, for the above-referred facility, indicating closure of the audit," Dr Reddy's said in a regulatory filing. 

The USFDA issues an EIR to the establishment that is the subject of an FDA or FDA-contracted inspection when the agency decides to close the inspection. 

In September last year, the US health regulator had made three observations after inspecting Dr Reddy's Laboratories' API Mirfield plant, United Kingdom.