FDA 483 - Orion Vision Group - March 29, 2017

Orion Vision Group, a manufacturer/repackager/relabeler of contact lenses in Marietta, GA, was cited for significant deficiencies in its quality system. Observations included inadequate complaint investigation records and procedures, undocumented corrective and preventive actions, conflicts of interest in quality audits, and a lack of regular management reviews of the quality system. These issues indicate a systemic breakdown in maintaining a compliant quality management system.