Dr Reddy's gets USFDA inspection closure report for Srikakulam manufacturing plant in Andhra Pradesh
Drug major Dr Reddy's Laboratories on Friday said the US health regulator has closed inspection of its manufacturing facility in Srikakulam, Andhra Pradesh
New Delhi: Drug major Dr Reddy's Laboratories on Friday said the US health regulator has closed inspection of its manufacturing facility in Srikakulam, Andhra Pradesh.
DRL gets EIR from @US_FDA for Srikakulam (CTO VI) unit. EIR indicates closure of inspection. Facility is determined as VAI. Srikakulam was issued warning letter in Nov 2015 & was under official action indicated.After this, all facilities under warning letter now determined as VAl pic.twitter.com/2HmwIJBKFw
— CNBC-TV18 (@CNBCTV18Live) May 8, 2020
The US Food and Drug Administration (USFDA) had issued a warning letter to the facility in November, 2015, after inspecting it in 2014.
"We have received the establishment inspection report from the USFDA, for the Srikakulam facility, indicating closure of the audit and the inspection classification of this facility," Dr Reddy's Laboratories said in a regulatory filing.
With this, all facilities under warning letter are now determined as ‘voluntary action indicated’, the drug major said.