# FDA 483 - Department of Veterans Affairs Medical Center - July 08, 2024

Source: https://www.globalkeysolutions.net/records/483/department-of-veterans-affairs-medical-center/992c6d5b-7882-423d-94fc-ade648916e56

> FDA 483 for Department of Veterans Affairs Medical Center on July 08, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Department of Veterans Affairs Medical Center
- Inspection Date: 2024-07-08
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: The FDA issued a Form 483 to the Department of Veterans Affairs Medical Center in Washington, DC, following an inspection of its Hospital Blood Bank/Transfusion Service. The inspection revealed two significant observations related to inadequate record-keeping for emergency blood transfusions and deficiencies in standard operating procedures and quality control for blood product storage coolers, including out-of-specification temperatures.

## Related Documents

- [483 - 2021-08-27](https://www.globalkeysolutions.net/records/483/department-of-veterans-affairs-medical-center/0151d4ec-62f0-4b36-972c-a2110713fcfc)

## Related Officers

- [La-tasha M. Gunter](https://www.globalkeysolutions.net/people/la-tasha-m-gunter/db9cd9cf-db0a-4c31-9f7c-24760750f34d)

Company: https://www.globalkeysolutions.net/companies/department-of-veterans-affairs-medical-center/bdf3b666-628a-4b01-9336-5507e190c9bd

Office: https://www.globalkeysolutions.net/offices/office-of-regulatory-affairs/ff91c598-cf72-4dbe-a2c8-7519c64cbc64