A unit of Singapore-based Biosensors International has denied a report it refused a U.S. FDA inspection request and was subsequently barred from selling its products in the United States, joining a rare list of companies in the same category.
The Regulatory Affairs Professionals Society, or RAPS, said in a story posted on its website that the details of the inspection, whether planned or unannounced, were not immediately available. The company however subsequently emailed FiercePharmaAsia to note the issue was a failure to respond within the mandatory time period and it is working with the FDA.
"The fact was we received the notification of FDA inspection on December 21, 2015, over the holiday time," said John Wong of investor relations at Biosensors in an email. "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."
Subsequently, the company said it had been in contact with the FDA and "received official notice from FDA that Biosensors will be removed from FDA's import alert."
The company makes medical devices, including drug-eluting stents, angioplasty balloons and blood pressure transducers among other items, and had been listed on the Singapore Stock Exchange until last year.
In November 2015, Citic Private Equity Funds Management, an early investor, paid SGD$1.1 billion ($787 million) to take the firm private.
RAPS said that Biosensors is just the fifth company to refuse an inspection, citing a list dated to 2013 that includes China's Intop Tech, Shanghai Realov Electronic Technology, India's Sewa Medicals and Taiwan's Morris Engineering Works.
Biosensors last year started sales of its BMX-J drug-eluting stent system in Japan, which at the time it said was the third-largest single-country market in the world, after the United States and China, for such devices.
RAPS also noted that the company's website advises that its drug-eluting stents, bare metal stents and angioplasty catheters are not approved by the U.S. FDA.
- here's the story from RAPS