FDA EIR - Dow Silicones Corporation - Carrollton Plant - September 14, 2016

An FDA inspection of Dow Corning Corporation's Carrollton Plant, located in Carrollton, KY, took place from September 13 to September 14, 2016. This initial, comprehensive inspection focused on the company's operations as a chemical manufacturer producing various food-grade silicone intermediates, including antifoam emulsions and fluids, which are used in applications such as coatings for carbonated soft drink machinery and lubricants for water systems. The regulatory oversight for this inspection was based on the CIN-DO FY'16 NHR Food Work Plan and Compliance Program 7303.803, specifically targeting Domestic Food Safety Program Inspections. During the review, inspectors examined records pertaining to pest control, interstate commerce, standard operating procedures, regulated products, and the HACCP plan for food-grade items. Observations were also made concerning pest control and sanitation practices in the food-grade manufacturing and processing areas. Crucially, the inspection concluded without any significant deficiencies or violations being identified. Consequently, no FDA Form 483 (Inspectional Observations) was issued to the firm. This outcome indicates that the facility was found to be in compliance with applicable food safety regulations during the inspection, and therefore, no specific regulatory actions were mandated for the company.