O’Ryan Industries received a warning letter for allegedly distributing its Endo 150 endoscopic light source and Omega ST sterilizer without having procedures for quality system management or medical device reporting.

The letter adds that the devices do not have PMAs or approved investigational device exemptions, and that the company distributed them without conducting a quality audit since 2006. The Vancouver, WA-based firm intends to move forward and has hired Eisner Safety Consultants to complete all FDA requirements for the product.

SOURCE: FDANEWS