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

by Gopalan on January 21, 2010 at 11:50 AM Corporate News

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.

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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.

Lupin’s Mandideep facility was also found to be lacking in controls to prevent contamination in defined areas regarding operations related to aseptic processing of products. The plant managers also failed to routinely calibrate, inspect, or check according to a written programme designed to assure proper performance of automatic, mechanical, or electronic systems.

“The USFDA issued a warning letter for the cephalosporin (antibiotic compounds) facility of the Mandideep plant (in Madhya Pradesh). The facility was inspected in November 2008 for a routine GMP (good manufacturing practices) inspection. As a result, Lupin had received 15 procedural observations,” Lupin sated in a press release while announcing its fourth quarter results for the period 2008-09.

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

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