FDA 483 - Boston University National Emerging Infectious Disease Laboratories - May 16, 2025

The FDA inspected Boston University National Emerging Infectious Disease Laboratories, a nonclinical laboratory in Boston, MA, and identified significant deficiencies. Observations included failures in quality assurance review of study reports, unauthorized deviations from standard operating procedures, inadequate archiving of raw data, and insufficient validation of electronic systems. These issues collectively point to concerns regarding data integrity and overall study management practices.