483
LifeSouth Community Blood Centers, Inc.FDA 483 - LifeSouth Community Blood Centers, Inc. - August 19, 2021
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An FDA inspection of LifeSouth Community Blood Centers, Inc. in Gainesville, FL, identified one observation. The firm failed to maintain proper temperature control for Red Blood Cells during shipment, specifically regarding apheresis concurrent Red Blood Cells not being stored on ice as required by SOPs for certain units. This issue could impact the quality and safety of the blood products.
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