FDA 483 - Avent, Inc. - February 21, 2020

Avent, Inc. in Tucson, AZ, was cited with three observations during an FDA inspection from February 18-21, 2020. The inspection revealed significant issues related to quality control, including inadequate investigation of discrepancies, insufficient equipment maintenance and calibration, and poor access controls for computer systems managing critical production and control records. These findings indicate a lack of robust quality management system practices.