# FDA 483 - Savannah Health Services, LLC dba Memorial Health University Medical Center - August 30, 2022

Source: https://www.keypedia.com/records/483/savannah-health-services-llc-dba-memorial-health-university-medical-center/c2760220-3ebc-4dfc-a791-a8b2ef36439d

> FDA 483 for Savannah Health Services, LLC dba Memorial Health University Medical Center on August 30, 2022. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Savannah Health Services, LLC dba Memorial Health University Medical Center
- Inspection Date: 2022-08-30
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Savannah Health Services, LLC dba Memorial Health University Medical Center in Savannah, GA, a blood irradiation facility, identified two observations. The firm failed to adequately validate linear accelerators used for irradiating blood and blood components. Additionally, the standard operating procedures lacked written schedules and procedures for equipment maintenance and calibration.

## Related Officers

- [Amy A. Johnson](https://www.keypedia.com/people/amy-a-johnson/9933f793-503f-45c5-8837-d46134c20e09)

Company: https://www.keypedia.com/companies/savannah-health-services-llc-dba-memorial-health-university-medical-center/1189e456-ec5b-4935-b727-04f617edb330

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