Sonneborn, LLC – FDA EIR, Jun 30, 2014

On June 30, 2014, the U.S. Food and Drug Administration (FDA), Philadelphia District, conducted an abbreviated Current Good Manufacturing Practice (CGMP) establishment inspection of Sonneborn, LLC, located in Petrolia, PA. This inspection was part of the FDA's FY14 Work Plan and followed Compliance Program 7356.002 for Drug Manufacturing Inspections.

Sonneborn, LLC manufactures Petrolatum USP, White Mineral Oil USP, and Microcrystalline Waxes, including products with food applications. The inspection reviewed the company's quality, packaging, labeling, and laboratory systems, encompassing a detailed look at analytical documentation for ten Petrolatum USP batch records from the current year.

Crucially, the inspection found no violations or discrepancies. No Form FDA 483, which lists inspectional observations requiring corrective actions, was issued. This outcome indicates that Sonneborn, LLC was operating in compliance with CGMP regulations during the inspection, and therefore, no specific actions were required from the company.