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

Source: https://www.keypedia.com/records/483/boston-university-national-emerging-infectious-disease-laboratories/90cabdcc-1217-4b4c-b6cd-4dc915181c12

> FDA 483 for Boston University National Emerging Infectious Disease Laboratories on May 16, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Boston University National Emerging Infectious Disease Laboratories
- Inspection Date: 2025-05-16
- Product Type: biologics
- Office Name: New England District Office
- Summary: 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.

## Related Officers

- [Andrew R. Wasko](https://www.keypedia.com/people/andrew-r-wasko/87f194a2-d86b-4dad-8319-07f107ad8e6a)
- [Matthew C. Watson](https://www.keypedia.com/people/matthew-c-watson/a1594b84-f65a-42f9-a06d-a68a49eb4b28)

Company: https://www.keypedia.com/companies/boston-university-national-emerging-infectious-disease-laboratories/050558e2-09bc-4c20-856b-d9bbdf2a9300

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144