Medtronic Subsidiary Warning Points to Validation Shortfalls

Medtronic subsidiary Invatec failed to verify or validate the effectiveness of employee retraining aimed at correcting too-high microbial counts on surfaces, an FDA warning letter says. During an early February inspection of Invatec’s Brescia, Italy facility, an FDA investigator found a 2012 risk assessment for the assembly area that showed microbial counts above the warning and action limits.
Devices & Diagnostics Letter