LifeSouth Community Blood Centers, Inc. - Marion RegionMay 10, 2023

FDA 483 - LifeSouth Community Blood Centers, Inc. - Marion Region - May 10, 2023

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Record Details

LifeSouth Community Blood Centers, Inc. in Ocala, FL, was inspected regarding its donor center operations. The inspection revealed that apheresis technicians were not consistently following written standard operating procedures for the collection of blood and blood components, specifically concerning the handling and labeling of samples. This indicates a procedural non-compliance and a lack of awareness among staff regarding established protocols.

Company: LifeSouth Community Blood Centers, Inc. - Marion Region
Inspection Date: May 10, 2023
Product Type: Biologics
Office: Office of Medical Device and Radiological Health Division II
Person: Barbara T. Carmichael (Investigator at U.S.FDA)

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ID · 4c97e3f3-3993-4c12-aa72-a0acb6b81a91