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The US Food and Drug Administration (USFDA) has completed its audit of Dr Reddy’s Laboratories formulations manufacturing facility at Duvvada, Visakhapatnam.
“We wish to inform you that the company has received the Establishment Inspection Report (EIR) from the USFDA indicating closure of the inspection,’’ Dr Reddy’s informed the Bombay Stock Exchange on Monday.
When contacted, a company spokesperson told BusinessLine: `Futher to the audit conducted by the USFDA at our formulations manufacturing facilities (FTO 7 & FTO 9) at Vizag, the company has received the Establishment Inspection Report (EIR) from the USFDA indicating closure of the inspection. This was a PAI-triggered inspection (product-related Pre-Approval Inspection).‘
``The Agency has issued some observations related to the pre-approval inspection. We will address them appropriately and in a timely manner. The Agency has concluded the inspection as closed. Manufacturing of other products and regular operations are not affected,’‘ the company added.
In October last year, Dr Reddy’s announced that the US regulator, after its inspection of the facilities (FTO 7 & FTO 9), had issued Form 483 with eight observations.
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