The FDA says it has scheduled an inspection with Singapore-based Biosensors International, following an import alert that banned the company’s medical devices.
Biosensors International manufactures interventional cardiology products, such as drug-eluting stents, bare metal stents and angioplasty catheters. It also manufactures critical care products, including vascular catheters, pressure monitoring kits, arterial blood sampling kits and blood pressure transducers, according to its website.
The interventional cardiology products are not approved by the FDA, and are not available for prescription or use in the U.S., the company’s website says.
The FDA issued the Jan. 15 import alert stating that Biosensors International barred an inspection by agency officials. However, CDRH spokesman Eric Pahon says the company actually did not refuse an inspection. Biosensors International was added to the import alert due to a delay in responding to a proposed inspection notice over the holidays, he says.
“FDA has now scheduled an inspection and is working to remove the company from the import alert,” he tells IDDM.
The company could not be reached for comment by press time.