FDA EIR - Kasel Associates Industries, Inc. - November 09, 2022

Kasel Associates Industries, Inc., a contract manufacturer of canine treat products, underwent an FDA surveillance inspection from November 7-9, 2022. The inspection was conducted under the Comprehensive Animal Food Inspections program, guided by the regulatory framework of 21 CFR Part 507 concerning current good manufacturing practices and preventive controls for animal food. While no formal FDA Form 483 (Inspectional Observations) was issued, the inspection identified two significant issues. Firstly, equipment and utensils were found not to be designed or used appropriately to prevent animal food adulteration, specifically noting employees handling cooked products with non-food-contact leather and cloth gloves, and the use of damaged pallets. Secondly, the plant's construction and design were not fully adequate to facilitate cleaning, maintenance, and pest control, with observations of water leaking from the oven room into the finished goods storage area and exterior debris creating pest harborage points. Company President Raymond Kasel acknowledged these concerns and committed to voluntary corrections, including implementing proper food-contact gloves, addressing the facility's structural issues, and cleaning up exterior areas. Some planned corrective actions require future onsite verification.