FDA 483 - National Genetics Institute

National Genetics Institute, a medical device (IVD) manufacturer in Los Angeles, CA, was cited for significant deficiencies in its quality system during an FDA inspection from January 10-19, 2017. The observations primarily concern data integrity issues with electronic records, failure to properly manage and report product changes, inadequate process control for testing equipment, and deficiencies in contamination prevention and corrective and preventive action procedures. These issues indicate a systemic lack of control over critical processes that could impact the safety and effectiveness of their diagnostic products.