Biosensors clarifies reported FDA product ban

It was caused by administrative errors.

Mainboard-listed Biosensors International Group, a developer, manufacturer and marketer of medical devices, has clarified reports stating that the US Food and Drug Administration (FDA) has banned the company from importing products to the US.

Biosensors said that FDA placed the company’s Critical Care Products on the Import Alert because it thought Biosensors International refused the scheduled routine inspection by the FDA by not responding to the notification letter within the required 5-day window. 

Biosensors said it received the letter on 21 December 2015 and responded that it would welcome the inspection on 11 January 2016.

“The delay was caused by administrative errors during the holidays. Biosensors received confirmation from the FDA on 19 January 2016 that Biosensors International would be removed from the Import Alert based on the company’s willingness to be inspected. The Company also wishes to emphasize that Biosensors view all regulatory compliance and inspections with utmost importance, including the FDA,” the company’s statement said.