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Dr Reddy’s Laboratories has received Establishment Inspection Report (EIR) for the company’s Medak units, from the US health regulator.
The company stated the exchanges that, it has received an EIR from the US Food and Drug Administration for units located in Medak district, Telangana.
Further, the US health regulator had completed audit of API Hyderabad Plant 3 at Bollaram and API Hyderabad Plant 1 at Jinnaram Mandal, Medak District, Telangana on March 9 and March 16, respectively. After the audit, the USFDA had issued a Form 483 with four observations for API Hyderabad Plant 1 and it issued a Form 483 with five observations for API Hyderabad Plant 3. Those observations were related to procedures and facility maintenance.
