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483
•LifeSouth Community Blood Centers, Inc.•August 19, 2021

LifeSouth Community Blood Centers, Inc. – FDA 483, Aug 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)
View Company Profile

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

Other documents for LifeSouth Community Blood Centers, Inc.
  • 483 - 2025-08-18August 18, 2025

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