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About Kreotc

  • Birthday 08/01/1980

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  1. That's how I read the guidance for industry document. Any conjectures as to where the idea that deviation reporting is voluntary came from? Thanks for the response.
  2. If an occurrence is noted in a transfusion service (i.e. issuing units for a patient with a positive antibody screen and no antibody identification is performed) and classified as reportable to the FDA by Quality, is reporting voluntary or required? If an occurrence is never reported and discovered during an inspection/investigation, what kind of repercussions will that have?
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