FDA 483 - Uberlube, Inc. - February 16, 2023

Uberlube, Inc., a medical device manufacturer in Skokie, IL, was inspected by the FDA and received nine observations, many of which were repeat findings from a 2019 inspection. The observations primarily concern inadequate procedures and documentation for process validation, corrective and preventive actions, equipment maintenance, acceptance activities, nonconforming product control, complaint handling, risk analysis, and device history records. These deficiencies indicate significant issues with the firm's quality system, potentially impacting product quality and patient safety.