The US Food and Drug Administration (USFDA) has placed the Active Pharmaceutical Ingredients (API) plant of Dr Reddy’s Laboratories Ltd at Srikakulam under ‘Voluntary Action Indicated (VAI)’ classification category.
“We have received the Establishment Inspection Report (EIR) from USFDA, for API manufacturing plant at Srikakulam, Andhra Pradesh (CTO VI) indicating closure of the audit and the inspection classification of this facility is determined as ‘Voluntary Action Indicated (VAI)’,” Hyderabad-based Dr Reddy’s informed the Bombay Stock Exchange on Friday.
The site was issued warning letter by the USFDA in November, 2015 after the inspection in 2014, and was under “Official Action Indicated” classification till now.
“With this, all facilities under the warning letter are now determined as VAl,” the company said.