FDA EIR - Univar Solutions USA LLC - November 28, 2016

This FDA Establishment Inspection Report details a routine surveillance inspection of Univar USA Inc.'s Morrisville, PA facility, conducted on November 28, 2016. The inspection was carried out in accordance with CP7356.002 Drug Manufacturing Inspection guidelines, focusing on the company's operations as a repacker and relabeler of pharmaceutical excipients such as USP Sorbitol, Isopropyl Alcohol, Glycerine, and Propylene Glycol. The regulatory framework covered storage, packaging, employee training, quality assurance, and labeling practices for these excipients. Univar USA Inc. maintains an up-to-date drug registration with the FDA. A key finding of the inspection was that no objectionable conditions or violations were observed. Consequently, no Form FDA 483, which would indicate observed deficiencies, was issued, and therefore, no specific corrective actions were required from the company. The report noted good environmental control with no evidence of pest activity. Management actively participated throughout the inspection.