483
Bard Shannon LimitedFDA 483 - Bard Shannon Limited - August 18, 2023
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Record Details
An FDA inspection of Bard Shannon Limited in Humacao, PR, a medical device manufacturer, revealed three significant observations. The firm failed to adequately establish and follow procedures for environmental control, specifically cleaning manufacturing areas, which was a recurrent issue. Additionally, the inspection found deficiencies in supplier performance management and a lack of documented employee training records for critical procedures.
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ID · 251bb236-df19-4443-b886-d0d75391eb7f