Home » Medtronic Subsidiary Warning Points to Validation Shortfalls
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
Devices & Diagnostics Letter
Upcoming Events
-
28Mar
-
04Apr
-
11Apr
-
14Apr
-
25Apr
-
14May