# FDA 483 - Greater Baltimore Medical Center - October 26, 2023

Source: https://www.globalkeysolutions.net/records/483/greater-baltimore-medical-center/1d2e977b-6c6c-4e45-a16f-21abc1864977

> FDA 483 for Greater Baltimore Medical Center on October 26, 2023. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Greater Baltimore Medical Center
- Inspection Date: 2023-10-26
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Greater Baltimore Medical Center's Hospital Blood Bank in Towson, MD, revealed significant deficiencies in equipment calibration and validation, as well as a failure to follow written standard operating procedures for recordkeeping. These issues indicate a lack of control over critical processes for blood and blood component testing and documentation.

## Related Officers

- [Richard J. Bashay](https://www.globalkeysolutions.net/people/richard-j-bashay/ce50702d-1f5b-42c5-b50a-88bb43cba196)

Company: https://www.globalkeysolutions.net/companies/greater-baltimore-medical-center/252bbb07-3732-43c3-a3ee-eccd341f8dc9

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