FDA 483 - TreeHouse Foods, Inc. - December 05, 2024

An FDA inspection of Treehouse Foods, Inc. in Cambridge, MD, an LACF/Aseptic Manufacturer, revealed significant repeat violations concerning process deviations of potential public health significance. The firm failed to properly investigate and report packaging failures and sterility issues, and did not ensure commercial sterility or adequately validate its clean-in-place (CIP) operations. These deficiencies indicate a serious lack of control over critical manufacturing processes for low-acid canned foods.