FDA EIR - Sonneborn, LLC - September 12, 2018

An FDA inspection of Sonneborn, LLC's Petrolia, PA facility, a manufacturer of mineral oil, petrolatum, and microcrystalline wax for food use applications, was conducted from September 10-12, 2018. The inspection was a limited-scope assessment focusing on Current Good Manufacturing Practices (cGMPs) and various food safety elements, including process controls, food allergen controls, sanitation controls, and the supply chain program. This audit was conducted under the regulatory framework of 21 Code of Federal Regulations (CFR) Part 117, addressing Hazard Analysis and Risk-Based Preventive Controls for Human Food, as mandated by the Food Safety Modernization Act (FSMA). Crucially, no significant deficiencies were observed, and therefore, no formal inspectional observations were issued at the conclusion of the inspection. Management was informed that no objectionable conditions were found. While no formal actions were immediately required, the FDA provided information on Preventive Controls for Human Food, signaling that future inspections would likely involve a comprehensive evaluation of the firm’s hazard analysis and risk-based preventive controls. The company maintains a valid food facility registration and has a Preventive Control Qualified Individual (PCQI) as part of its Food Safety Team.