USFDA issues ban on products made by Srikem Labs' Taloja unit

The US health regulator has banned import of drugs and drug products made by Mumbai-based Srikem Laboratories at its Taloja facility in Maharashtra for violations of manufacturing norms.

As per US Food and Drug Administration (USFDA) website, it has issued an 'Import Alert 66-40' against the products made at the Taloja facility.

This allows for "detention without physical examination of drugs from firms which have not met drug GMPs," the alert says.

The health regulator further said such detentions remains in effect until such time as FDA is satisfied that the appearance of a violation has been removed, either by reinspection or submission of appropriate documentation to the responsible FDA Centre.
 

Srikem Laboratories manufactures bulk drug and pharmaceutical actives at its Taloja facility.