FDA 483 - Blood Assurance Inc - February 17, 2026

On February 17, 2026, the U.S. Food and Drug Administration (FDA) conducted an inspection of Blood Assurance Inc., located in Tullahoma, Tennessee. This facility operates as a donor center for blood and blood components. The inspection resulted in the issuance of Form FDA 483, which documented a significant violation regarding the firm"s donor eligibility screening process. Specifically, the center failed to disqualify donors who presented with body temperatures exceeding 99.5°F. The investigator noted that since October 24, 2022, the facility collected blood and red cell units from numerous donors with elevated temperatures, including instances reaching 100.0°F. This lapse was attributed to a failure to establish and maintain adequate standard operating procedures that define the correct maximum temperature threshold for donor safety and product quality. These observations were made under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. While this report does not constitute a final legal determination of non-compliance, Blood Assurance Inc. is expected to implement corrective actions to align its procedures with federal safety standards. The firm has the opportunity to submit a formal response to the FDA detailing its plans to address these screening deficiencies and ensure future compliance.