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Dr Reddy’s Laboratories Ltd on Wednesday said it has received an Establishment Inspection Report (EIR) from US Food and Drug Administration (FDA) for its formulations plant located in a Special Economic Zone at Srikakulam in Andhra Pradesh.
”.. with regard to the audit of our Formulations Srikakulum Plant (SEZ) Unit I, Andhra Pradesh, we would like to inform you that we have received the Establishment Inspection Report from US FDA..,” Dr Reddy’s said in disclosure.
The report indicates closure of the audit and the inspection classification of the facility was determined as ‘No Action Indicated” (NAI).
The drug maker on May 8 said it received the EIR from US FDA, for its API manufacturing plant at Srikakulam, (CTO VI) indicating closure of the audit and the inspection classification of this facility was determined as “Voluntary Action Indicated” (VAI).
The site was issued a warning letter in November, 2015 after the inspection in 2014, and was under “Official Action Indicated” classification.
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