Kasel Associates Industries, Inc. – FDA 483, Sep 28, 2012

An FDA inspection conducted from September 19-28, 2012, at Kasel Associates Industries, Inc., a pet food manufacturer in Denver, CO, revealed multiple significant deviations from current good manufacturing practices. The FDA 483 document outlined eight primary observations. Critical issues included widespread sanitation deficiencies, such as accumulated food debris on equipment and surfaces, fraying conveyor belts, and product stored in unsanitary containers like reused cardboard totes and dirty plastic garbage cans. Furthermore, pest control was severely lacking, with evidence of extensive insect infestation (larvae, worms, moths, cockroaches, flies) and rodent activity (dead mouse, excreta) throughout the facility, exacerbated by structural gaps and disorganization. The inspection also noted a failure to prevent foreign material contamination, highlighted by a non-functioning metal detector, metal hooks in products, and direct contact between wooden pallets with loose nails and finished goods. Cross-contamination risks were high, as the company lacked a system to separate raw and finished product equipment and allowed shared traffic paths. Finished and in-progress products were often stored uncovered or in direct contact with the floor, exposing them to physical and microbial contamination, including an instance of sanitizer spray on frozen chicken chips. Finally, the facility's physical structure was in disrepair, with unsealed floors, damaged ceilings and walls, and non-functional handwashing sinks, compounded by observed employee failures to adhere to basic hand hygiene protocols. Kasel Associates Industries, Inc. is required to implement comprehensive corrective actions to address these serious violations and ensure compliance with regulatory standards.