FDA 483 - ULab Systems, Inc. - July 23, 2019

ULab Systems, Inc., a medical device manufacturer in Redwood City, CA, was cited for deficiencies in its complaint handling system. The inspection revealed that the firm failed to review, evaluate, and investigate device failure complaints in a timely manner. Multiple UDesign Software complaints remained open without any root cause investigations, indicating a significant lapse in their quality system.