# FDA 483 - Blood Connection Incorporated (The) - January 13, 2026

Source: https://www.keypedia.com/records/483/blood-connection-incorporated-the/0b045575-cff2-4d17-8dbd-39e650783774

> FDA 483 for Blood Connection Incorporated (The) on January 13, 2026. Product: biologics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Blood Connection Incorporated (The)
- Inspection Date: 2026-01-13
- Product Type: biologics
- Office Name: FDA District Office — Atlanta, Georgia
- Summary: The Blood Connection - Lexington, a donor center and blood bank, was cited for failing to thoroughly investigate and document recurring high temperature alarms in a refrigerator storing blood and blood products. For an eight-month period, personnel silenced hundreds of alarms without proper documentation or root-cause analysis, leading to blood components being stored outside required temperature specifications. This indicates significant deficiencies in quality control and record-keeping practices.

## Related Officers

- [Kenneth L. Smalls](https://www.keypedia.com/people/kenneth-l-smalls/7625258c-cada-4506-8daa-a64374cf9f15)

Company: https://www.keypedia.com/companies/blood-connection-incorporated-the/7c9b4123-f5cf-4faf-a8a9-17025e7995f9

Office: https://www.keypedia.com/offices/fda-district-office-atlanta-georgia/bae3b8c4-4161-4e9f-b5d1-e0e80b6abd43