FDA 483 - 180 Innovations LLC - January 29, 2020

An FDA inspection of 100 Innovations LLC, a repackager/relabeler in Lakewood, CO, revealed significant deficiencies in their quality system. The firm failed to adequately establish procedures and documentation for complaint handling, rework of nonconforming products, statistical techniques for process control, and device history records. These issues indicate a systemic lack of adherence to quality system regulations.