# FDA 483 - Geisinger Medical Center Blood Bank - January 24, 2019

Source: https://www.keypedia.com/records/483/geisinger-medical-center-blood-bank/2f55bf93-5094-4a15-85a2-73454285c185

> FDA 483 for Geisinger Medical Center Blood Bank on January 24, 2019. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Geisinger Medical Center Blood Bank
- Inspection Date: 2019-01-24
- Product Type: biologics
- Office Name: Philadelphia District Office
- Summary: An FDA inspection of Geisinger Medical Center's Hospital Blood Bank in Danville, PA, revealed significant deficiencies in record-keeping and equipment calibration. The facility failed to thoroughly investigate biological product deviations and maintain complete records for emergency blood product releases. Additionally, annual calibration records for critical storage equipment were missing, indicating a lack of control over blood and blood component handling.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/cara-minelli/23ac8da5-9b62-4be6-a258-54fab84fa646)

Company: https://www.keypedia.com/companies/geisinger-medical-center-blood-bank/9f4506a2-4fe0-4222-a726-a699e9c7e943

Office: https://www.keypedia.com/offices/philadelphia-district-office/c5ec7398-b3d5-4125-9793-fb7b972578d8