FDA EIR - Koster Keunen Inc - October 19, 2017

An FDA inspection of Koster Keunen Inc., a manufacturer and direct importer of wax products for various applications, including food, was conducted on October 19, 2017. The inspection identified several facility maintenance and hygiene issues. These included a half-inch air gap at the bottom of an overhead door in the shipping area, standing water on the floor in a processing area, an uncovered bucket of standing water behind the packing area, and a scoop used for adjusting product weight being stored improperly on a hopper ledge. The company had previously corrected observations from its 2015 inspection. The firm's Vice President of Quality and Regulatory, Mr. David Quinn, acknowledged and agreed with the current findings. The inspection concluded with a "Voluntary Action Indicated (VAI)" classification, signifying that while objectionable conditions were observed, they did not warrant immediate official regulatory action. The FDA issued guidance sheets related to the Food Safety Modernization Act (FSMA) concerning intentional adulteration, sanitary transportation, and preventive controls, indicating an expectation for Koster Keunen Inc. to voluntarily address the identified deficiencies to maintain compliance with food safety standards.