FDA 483 - Ice Cream Specialties Inc - September 30, 2025

Ice Cream Specialties Inc. received an FDA Form 483 following an inspection conducted from September 9-30, 2025, highlighting significant manufacturing deficiencies. The primary violations involved inadequate sanitation preventive controls. The firm’s Food Safety Plan was found insufficient to control biological hazards, specifically Listeria and Salmonella, in Ready-to-Eat (RTE) products. This was evidenced by persistent positive environmental and finished product test results for these pathogens over two years, indicating that current corrective actions were ineffective.

Additional observations included critical breaches of Good Manufacturing Practices. Employees were observed not adhering to personal cleanliness standards, with uniforms contacting product contact surfaces after touching floors or performing cleaning tasks, and soiled protective wear not being changed. Condensation was frequently seen dripping onto RTE product molds, raw ingredients, and packaging. Facility and equipment sanitation was also cited, with excessive dirt, debris, rust, and apparent mold on surfaces and equipment near RTE products. Furthermore, the firm failed to identify and implement a process preventive control for physical hazards, such as wood, despite repeated customer complaints and direct observations of stick fragments in production machinery and over unfrozen RTE product. Ice Cream Specialties Inc. is required to provide a comprehensive response detailing corrective actions for these critical observations.