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Medical Devices / Inspections and Audits

Alba Bioscience Cited for Device Reporting, Document Control

Jan. 22, 2019

Alba Bioscience did not properly implement medical device reporting procedures or document control procedures, the FDA said following a September 2018 inspection.

The FDA issued a Form 483 following its inspection of the firm’s Edinburgh, Scotland facility and found it had not implemented medical device reporting procedures for several licensed in vitro diagnostic devices, including blood grouping reagents, reagent red blood cells and anti-human globulin.

The inspection also determined the facility had not established controls for electronic data acquisition systems and found a failure to prevent unauthorized changes to data.

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