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Biosensors to be removed from FDA's Import Alert list
BIOSENSORS International Group said it had received confirmation from the US Food and Drug Administration (FDA) on Tuesday that it would be removed from the Import Alert given its willingness to be inspected.
The heart device manufacturer said this in a statement to Singapore Exchange on Wednesday to clarify certain media reports that its products have been banned by the FDA.
The FDA had placed Biosensors' critical care products on the Import Alert because it thought that the firm had refused the scheduled routine inspection as it had not responded to the notification letter within the stipulated five-day window, explained the firm.
Biosensors said it received the letter on Dec 21, 2015, and responded that it would welcome the inspection on Jan 11, 2016, attributing the delay to "administrative errors during the holidays".
The company reiterated that it views all regulatory compliance and inspections with utmost importance, including the FDA.
Shares of Biosensors slipped one Singapore cent or 1.3 per cent to 77.5 Singapore cents on Wednesday.