# FDA 483 - Department of Defense - Navy - September 08, 2023

Source: https://www.keypedia.com/records/483/department-of-defense-navy/6bee1f18-4340-4ed3-9f25-4511ffe0530b

> FDA 483 for Department of Defense - Navy on September 08, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Department of Defense - Navy
- Inspection Date: 2023-09-08
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: An FDA inspection of Naval Medical Center Camp Lejeune's Hospital Blood Bank and Transfusion facility identified issues with record-keeping practices. Specifically, employees were observed not concurrently documenting donor vital signs and other screening information directly into the computer system during blood collection, leading to concerns about data traceability. This indicates a lapse in maintaining accurate and timely records for significant steps in blood and blood component collection.

## Related Officers

- [Marla A. Cassidy](https://www.keypedia.com/people/marla-a-cassidy/d2859ca5-e77b-4385-9a96-4c785f3ac4c6)

Company: https://www.keypedia.com/companies/department-of-defense-navy/51423087-2e2a-40d2-938d-70170300f0c1

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7