OneBlood, Inc.July 20, 2021

FDA 483 - OneBlood, Inc. - July 20, 2021

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Record Details

OneBlood, Inc. in Tallahassee, FL, a blood bank, was cited for deficiencies in equipment standardization and calibration. The inspection revealed issues with performing required quality control checks and inadequate documentation of equipment maintenance and QC events.

Company: OneBlood, Inc.
Inspection Date: July 20, 2021
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 · 41cc29a9-a809-4102-a3ee-eba855ff5d61