FDA EIR - Packaging Coordinators, LLC - September 06, 2017

An FDA inspection of Packaging Coordinators, Inc. (PCI), a contract packer of human and animal drug products in Philadelphia, PA, was conducted from August 29 to September 6, 2017. This abbreviated cGMP inspection, performed under Compliance Program 7356.002 for drug manufacturers, evaluated the company's quality, materials, and packaging and labeling systems. The inspection concluded with no Form FDA 483 issued, indicating that no new significant regulatory violations were identified. Consequently, no new immediate corrective actions were required by the FDA as a direct result of this inspection. The report confirmed PCI's ongoing function as a pharmaceutical contract packager. The inspection team reviewed the firm's training program, manufacturing operations, quality management system, and processes for addressing customer complaints and Field Alert Reports. Although the firm had managed several past incidents, such as foreign objects, incorrect dosages, or labeling discrepancies, the inspection found the firm's investigations and corrective measures for these historical events to be satisfactory and without objection.