483
Princeton Community Hospital AssociationPrinceton Community Hospital Association – FDA 483, Jul 27, 2022
Record Details
Princeton Community Hospital Association's blood bank was inspected from July 25-27, 2022, revealing a significant issue with the establishment and adherence to written standard operating procedures. Specifically, new equipment was validated and put into use without prior approval from the Laboratory Medical Director, and no formal SOP existed for equipment validation. This indicates a lapse in quality assurance and procedural control.
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