FDA 483 - Lifesouth Community Blood Centers Inc. - East Alabama Region - March 26, 2025

Following an inspection on March 26, 2025, the U.S. Food and Drug Administration (FDA) issued a Form 483 to Lifesouth Community Blood Centers Inc., specifically targeting its East Alabama Region donor center in Opelika. The report identifies several critical deficiencies regarding blood testing protocols and quality management. A primary concern was the facility’s failure to investigate discrepancies between internal ABO blood grouping results and those produced by their contract laboratory. Additionally, the investigator found that since 2019, the center had not performed required daily quality control testing on blood grouping reagents, nor were these reagents always used according to manufacturer instructions. Documentation practices were also cited as inadequate, particularly the failure to record reagent storage temperatures and lot numbers since June 2024. Finally, the facility lacked essential Standard Operating Procedures (SOPs) to ensure that reagents were tested regularly for performance. These observations were made under the regulatory framework of the Federal Food, Drug, and Cosmetic Act. While the Form 483 serves as a report of objectionable conditions rather than a final legal determination, Lifesouth is required to respond. The firm should provide a detailed written plan of corrective actions to address these procedural gaps, ensuring future compliance with federal safety and quality standards for blood collection.