# FDA 483 - Johns Hopkins Hospital Blood Bank - February 13, 2025

Source: https://www.globalkeysolutions.net/records/483/johns-hopkins-hospital-blood-bank/f50a0fc7-eac5-4055-bf07-09bc573b0fb5

> FDA 483 for Johns Hopkins Hospital Blood Bank on February 13, 2025. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Johns Hopkins Hospital Blood Bank
- Inspection Date: 2025-02-13
- Product Type: biologics
- Office Name: Baltimore District Office
- Summary: An FDA inspection of Johns Hopkins Hospital's Blood Bank/Transfusion Service revealed significant deficiencies in record-keeping and standard operating procedures. The hospital failed to maintain physician signatures for emergency blood product releases and lacked adequate SOPs for compatibility testing and distribution of blood components. These issues indicate a need for improved documentation and procedural controls in critical transfusion processes.

## 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/johns-hopkins-hospital-blood-bank/2c291354-184f-4310-8268-8cec594b54aa

Office: https://www.globalkeysolutions.net/offices/baltimore-district-office/6be371ff-03e9-4039-999c-ff170f17a9fa