A Singapore-based medical device firm has been banned from importing their medical devices for interventional cardiology and critical care procedures into the U.S., according to the Regulatory Affairs Professionals Society.
The ban was prompted after a subsidiary of Biosensors International refused an FDA inspection.
It was not immediately clear why the company, "refused or failed to complete the inspection," according to the article.
The article explained that their first Singapore audit was in 1992 and, "in 2005, the company said its Singapore manufacturing sites achieved ISO 13485 certification and in 2008 it received a CE mark for its BioMatrix abluminal biodegradable polymer drug-eluting stents."
