FDA 483 - National Genetics Institute - March 02, 2022

National Genetics Institute, a contract testing laboratory in Los Angeles, CA, was cited for three observations during an FDA inspection. The firm failed to submit required supplements for changes involving non-licensed applications and lacked proper documentation for reporting these tests. Additionally, there were no written procedures for personnel to change Personal Protective Equipment when moving between different testing areas, and storage controls for both licensed and unlicensed samples and products were found to be inadequate, risking mix-ups.