Form 483

The FDA-483 is the written notice of objectionable practices or deviations from the regulations that is prepared by the FDA investigator at the end of an inspection. The items listed on the form serve as the basis for the exit discussion with the researcher at which time the PI can either agree or disagree with the items and can offer possible corrective actions to be taken. The PI may also respond to the district office in writing after it has had sufficient time to properly study the FDA-483 (hyperlink). The receipt of and a PI’s response to the Form 483 is submitted to IRB as an ORIO.