Sonneborn, LLC – FDA EIR, Nov 1, 2021

Sonneborn, LLC, a manufacturer of food-grade mineral oil, petrolatum, and microcrystalline wax located in Petrolia, PA, underwent a routine FDA inspection on November 1, 2021. This surveillance inspection served as a follow-up to a Class 1 Recall and a previous injunction, and was conducted under the framework of the FDA's Preventive Controls and Sanitary Human Food Operations program, with a specific focus on limited scope preventive controls in accordance with 21 CFR Part 117. The inspection comprehensively assessed the company's training program, manufacturing operations, food safety plan, process and sanitation controls, food allergen management, supply chain program, consumer complaint handling, and pest control. Review of the firm’s food safety plan indicated a written and implemented system covering all required elements, including process, sanitation, and supply chain preventive controls, consistent with Food Safety Modernization Act (FSMA) requirements. The company maintains a current food facility registration and holds a Food Safety System Certification 22000. Crucially, the inspection identified no main violations or deficiencies. Consequently, the FDA did not issue a Form FDA 483, Inspectional Observations, at the close of the inspection, and no verbal observations or required corrective actions were communicated to firm management. No samples were collected, and no pest activity or food safety-related complaints were noted, indicating full compliance during this assessment.