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Torrent Pharma says US FDA issues 'EIR' for company's manufacturing facility
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Torrent Pharmaceuticals on Thursday said that the US Food and Drug Administration (US FDA) has issued an Establishment Inspection Report (“EIR”) for the company's manufacturing facility at Dahej, Gujarat.
EIR means closure of inspection.
It said that inspection has now been successfully closed by the US FDA. Earlier in March 2019, the Dahej facility was placed under Official Action Indicated (OAI) by the US FDA.
The drug regulator had conducted re-inspection of the site in May this year from 17-25-May and issued Form 483 with 2 observations, the company said in a statement.
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