O'Ryan Industries receives warning letter
Device Regulation Alert: Safety, Compliance and Reimbursement News, September 15, 2008
O’Ryan Industries allegedly distributed its Endo 150 endoscopic light source and Omega ST sterilizer without having procedures for quality system management or medical device reporting, according to an FDA warning letter.
In addition, O’Ryan Industries does not have an approved application for pre-market approval, an approved application for an investigational device exemption, and did not notify the agency it planned to distribute the devices, the FDA said.
The agency cited 13 problems with the company’s quality systems, including:
- No audit procedures
- No established procedures for acceptance activities
- No way to track and evaluate complaints
- No device master records or device history records
O’Ryan Industries hired Eisner Safety Consultants to complete all FDA requirements for the product.
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