FDA EIR - Sonneborn, LLC - July 10, 2019

An FDA establishment inspection of Sonneborn, LLC, a manufacturer of mineral oil, petrolatum, and microcrystalline wax with pharmaceutical applications, was conducted in Petrolia, PA, from July 9 to July 10, 2019. The inspection, carried out under Compliance Program 7356.002 for Drug Manufacturing Inspections, aimed to evaluate the facility's adherence to regulatory standards. A significant outcome of the inspection was the absence of any critical observations or violations. No Form FDA 483, "Inspectional Observations," was issued to company management at the conclusion of the inspection, and no additional issues were verbally discussed. This reflects a state of compliance, consistent with the previous inspection in December 2017, which also resulted in "No Action Indicated." The inspection encompassed reviews of various aspects, including operations, complaint handling, and recall procedures, all of which were found to be satisfactory. Consequently, no specific regulatory actions or corrective measures are required from Sonneborn, LLC as a result of this inspection.