Swiss medical light therapy manufacturer Bioptron failed to properly deal with products that didn’t meet specifications and it lacked proper documentation, FDA investigators found in an inspection of the company’s Wollerau facility.
The company lacked definitions for events that needed to be reported to the FDA. For example, there were no definitions for MDR reportable events, serious injuries, or malfunctions, and there were no reporting timeframes for MDRs.
The facility lacked documentation for design input requirements and procedures for design reviews. For example, investigators noted that no documentation identified verification testing for a software revision and the critical components at the time of testing.