# FDA 483 - Department of Defense - Army - May 09, 2025

Source: https://www.globalkeysolutions.net/records/483/department-of-defense-army/e8549448-ae98-478c-b525-8fee25ecbcc4

> FDA 483 for Department of Defense - Army on May 09, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Department of Defense - Army
- Inspection Date: 2025-05-09
- Product Type: biologics
- Office Name: Atlanta District Office
- Summary: An FDA inspection of D. D. Eisenhower Army Med. Ctr. in Fort Eisenhower, GA, a military blood bank and donor center, revealed two significant observations. The inspection found issues with phlebotomy site preparation, specifically regarding maintaining sterility during whole blood collection. Additionally, the firm failed to consistently follow standard operating procedures for donor lookback and deferral, leading to a lack of Medical Director determination and recipient notification for transfused units in lookback cases.

## Related Documents

- [483 - 2023-03-24](https://www.globalkeysolutions.net/records/483/department-of-defense-army/d55c2645-690d-403d-9ceb-052de91b1fb9)

## Related Officers

- [Steven D. Banks](https://www.globalkeysolutions.net/people/steven-d-banks/30e4d016-e386-423d-9df8-1536cf43a0a3)

Company: https://www.globalkeysolutions.net/companies/department-of-defense-army/4c97b377-c014-4805-b35d-566c032e9c2c

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