FDA 483 - River's Edge Pharmaceuticals, LLC - April 01, 2011

River's Edge Pharmaceuticals, LLC, an own label drug distributor in Suwanee, GA, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to make records readily available, lacked adequate quality control unit oversight of contract manufacturers, and did not have written procedures for critical quality functions. Additionally, the customer complaint handling procedures were found to be deficient, particularly regarding the assessment of adverse events.