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

Source: https://www.globalkeysolutions.net/records/483/lexington-medical-center/922a7548-245f-4d81-b206-d8a945f5b87b

> 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: Atlanta District Office
- Summary: An FDA inspection of Lexington Medical Center's Hospital Blood Bank in West Columbia, SC, revealed significant deficiencies in record-keeping and adherence to standard operating procedures. The facility failed to maintain physician signatures for emergency blood transfusions and did not consistently follow its quality control procedures for processing blood components. These issues indicate a moderate level of non-compliance in critical blood bank operations.

## Related Documents

- [483 - 2020-01-15](https://www.globalkeysolutions.net/records/483/lexington-medical-center/068bb9fe-14a0-4753-afa9-84b733a7fe59)

## Related Officers

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

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

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7