US FDA ‘Satisfied’ With Indian Pharma’s Manufacturing Facility

Indian pharma major Lupin says the US FDA is now satisfied with the corrective actions taken at its Mandideep facility in Madhya Pradesh. An official communication has been received from the US agency on the issue.
In May last year, the FDA had warned the company that no new product would be approved until it took corrective action to address the deficiencies in the Mandideep manufacturing plant. It is Lupin’s only plant manufacturing cephalosporins, which contribute about 45% of its total revenue.
The FDA inspection found several deficiencies in the Good Manufacturing Standards (GMP) standards set by the agency and issued Inspectional Observations also known as Form 483 listing all the deviations.
It cited Lupin’s failure to maintain production, control, or distribution records and failure to follow appropriate written procedures designed to prevent microbiological contamination of drug products to be sterile....................&more