A subsidiary of Biosensors International, a group of companies developing, manufacturing and marketing medical devices for cardiology and critical care procedures, failed to respond to an inspection request from the US Food and Drug Administration (FDA) and its products were banned from entering the US. However, five days after the company's name was posted on the import alert list, a Biosensors spokesman told Focus that the company will be removed from the list after discussions with FDA.
Biosensors spokesman John Wong told us in an email that the company did not actually refuse the inspection and that as of Tuesday evening, the company would no longer be on the import alert list. Initially Wong said the company "received the notification of FDA
inspection on December 21, 2015 over the holiday time. As we did not respond to
FDA within the 5-day window as required by the FDA due to the holidays, we
missed the required deadline."
Biosensors was just the fifth company to be included on this FDA list of companies refusing an inspection dating back to 2013. The others still listed are China’s Intop Tech Co., Shanghai Realov Electronic Technology Co., India’s Sewa Medicals and Taiwan’s Morris Engineering Works.
The short list reveals how rare it is for a medical device company with products intended for the US market to deny or fail to allow the completion of an inspection by FDA at a facility.
And as FDA makes clear, the inspections are an important part of ensuring a foreign company’s products are safe and manufactured appropriately, so if an inspection is denied or not completed, then the agency has no choice but to declare the company’s products adulterated.
“Access to these facilities is a critical aspect of protecting the health and safety of US citizens from unsafe products of foreign origin,” FDA says, noting that it can perform both unannounced and scheduled inspections.
Biosensors is part of a group of companies with products in multiple international markets and had its first FDA audit at its Singapore site back in 1992. The company spokesman told Focus that the site was last inspected by FDA in August 2010 and that it's audited annually by a notified body and other regulators. In 2005, the company said its Singapore manufacturing site achieved ISO 13485 certification and in 2008 Biosensors received a CE mark for its BioMatrix abluminal biodegradable polymer drug-eluting stents.
The firm does make clear on its website, however, that the drug-eluting stents, bare metal stents and angioplasty catheters are commercialized in certain areas, but are not approved by FDA and are not available for use in the US.
According to Bloomberg, the Chinese private-equity arm of Citic Group Corp. bought what it didn't already own of Biosensors for about $817 million in November.
Import Alert List