LifeSouth Community Blood Centers, Inc.August 18, 2025

FDA 483 - LifeSouth Community Blood Centers, Inc. - August 18, 2025

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Record Details

LifeSouth Community Blood Centers, Inc. in Gainesville, FL, was inspected by the FDA from August 12-18, 2025. The inspection revealed a significant issue concerning the firm's failure to adhere to manufacturer instructions for ABO blood grouping reagents. This included deficiencies in performing quality control testing and documenting reagent storage temperatures.

Company: LifeSouth Community Blood Centers, Inc.
Inspection Date: August 18, 2025
Product Type: Biologics
Office: Office of Medical Device and Radiological Health Division II
Person: Laura E. Garcia

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ID · c2c4704f-9554-4beb-ad4f-752b86bfa85d