USFDA issues establishment inspection report for NATCO Pharma’s Chennai plant

NATCO PHARMANATCO pharma, a Hyderabad based pharmaceutical company, said it received establishment inspection report (EIR) from the U.S. Food and Drug Administration (FDA) for the inspection conducted during the period February 8 – February 12 at its Chemical Division in Chennai.

Earlier in mid-August, US FDA had issued an establishment inspection report to Natco Pharma’s for its Kothur facility in Telangana.

Establishment Inspection Report is issued after the completion of an audit, and violations noticed during the inspection could result in the suspension of marketing approvals for products made in the plant. NATCO said the establishment report for the Chennai plant was ‘successful’.

EIR incorporates consolidated inspection findings of the inspection team.