Search results with tag "Fda audit readiness"

FDA Audit Readiness - ASCO

findings with PI. If warranted, Form 483 issued Investigator responds within 15 days. FDA inspection report issued. Inspection classified by FDA Regional Office. If warranted, warning letter issued PI responds. Potential re-audit. FDA reviews PI response. There are several elements within the FDA audit process for which the investigator and ...

  Findings, Response, Audit, Readiness, Fda audit readiness