Roquette America Corp. – FDA EIR, Nov 5, 2019

An FDA inspection of Roquette America Corp., a facility located in Gurnee, Illinois, that manufactures powdered and liquid sorbitol primarily used in food products like gums, mints, and toothpaste, was conducted on November 5, 2019. This one-day inspection adhered to regulatory frameworks outlined in 21 CFR Part 117, which encompasses Current Good Manufacturing Practices (cGMP) and Hazard Analysis and Risk-Based Preventive Controls for Human Food. During the visit, investigators observed the firm processing and packaging powdered sorbitol. The main observation highlighted during the closeout meeting was the presence of residues on overhead piping and conduit within a specific operational area. In response to this finding, Mr. Steve Calewarts, the Plant Manager, confirmed that the company would expedite its routine cleaning schedule to address and rectify the noted condition. The inspection report did not document any other significant objectionable conditions, nor were any physical samples or photographic evidence collected. The company's previous FDA inspection in April 2013 had concluded with no adverse findings.