FDA 483 - Kimberly-Clark Corporation Cold Spring - July 25, 2019

An FDA inspection of Kimberly-Clark Corp. in Neenah, WI, revealed a significant issue with the control of non-conforming product. The firm's procedures for managing non-conforming product were found to be inadequately established, specifically regarding the documentation of the process for identifying, isolating, and scrapping/reclaiming such products. This indicates a moderate severity issue related to quality system controls.