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FDA Audit Support

CRSO QA provides FDA Audit support to all investigators at the University of Utah. Study teams are required to notify CRSO QA immediately when they receive notice of an impending FDA audit. Services provided may include:

  1. Pre-review of study materials prior to the audit (if prior notification is given).
  2. Educating investigators and study teams on proper audit conduct (including how to interact with the inspector and what role the sponsor should play).
  3. Attending opening and daily closing meetings with the inspector and study team.
  4. Providing guidance throughout the audit.
  5. Assisting with audit findings and writing 483 responses, if one is issued.
  6. Please see UUSOP-02: FDA Inspections for additional information.