LifeSouth Community Blood Centers, Inc.August 19, 2021

FDA 483 - LifeSouth Community Blood Centers, Inc. - August 19, 2021

Record Details

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.

Company: LifeSouth Community Blood Centers, Inc.
Inspection Date: August 19, 2021
Product Type: Biologics
Office: Office of Medical Device and Radiological Health Division II
People: Barbara T. Carmichael (Investigator at U.S.FDA)
Thai D. Truong (Investigator)

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ID · 40662cbf-c7f7-4ee0-ad00-b2fd7b1e2fcd