Dr Reddys gets EIR from USFDA for 2 units at Medak in Telangana
New Delhi: Drug firm Dr Reddy’s Laboratories on Thursday said it has received establishment inspection report (EIR) from the US health regulator for its two units at Medak district in Telangana.
In an earlier filing to the bourses on 9 March, the drug firm had said it had received five observations from the US Food and Drug Administration (USFDA) for its API Hyderabad plant 3 at Medak district.
On 16 March, the company intimated the bourses that it had been issued a Form 483 with four observations for its API Hyderabad plant 1 at Jinnaram Mandal, Medak district.
“...we have received an establishment inspection report (EIR) from the USFDA, for both of the above-referred facilities,” Dr Reddy’s said in a filing to BSE.
As per the USFDA, after the completion of an inspection of a facility, an EIR is issued to a company detailing inspectional findings.