# FDA 483 - Lexington Medical Center - October 30, 2024

Source: https://www.keypedia.com/records/483/lexington-medical-center/ac276d33-4172-400b-be27-5d3b1410ddc7

> FDA 483 for Lexington Medical Center on October 30, 2024. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lexington Medical Center
- Inspection Date: 2024-10-30
- Product Type: biologics
- Office Name: Office of Regulatory Affairs
- Summary: An FDA inspection of Lexington Medical Center, a hospital blood bank in West Columbia, SC, identified two significant observations. The facility failed to maintain complete records for emergency transfusions, specifically lacking physician signatures for numerous blood and blood product units. Additionally, the firm did not consistently follow its written standard operating procedures for processing blood and blood components for allogeneic transfusion, particularly concerning quality control log documentation.

## Related Documents

- [483 - 2020-01-15](https://www.keypedia.com/records/483/lexington-medical-center/068bb9fe-14a0-4753-afa9-84b733a7fe59)
- [483 - 2024-10-30](https://www.keypedia.com/records/483/lexington-medical-center/922a7548-245f-4d81-b206-d8a945f5b87b)

## Related Officers

- [Kenneth L. Smalls](https://www.keypedia.com/people/kenneth-l-smalls/7625258c-cada-4506-8daa-a64374cf9f15)
- [Danielle R. Rainey](https://www.keypedia.com/people/danielle-r-rainey/c4c42fe2-838c-4746-a316-4c5db6dd0832)

Company: https://www.keypedia.com/companies/lexington-medical-center/9dc08ec7-0424-445a-9b58-63c094fd3012

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