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 the inspection. The items
listed on the form serve as the basis for the exit discussion with laboratory management at
which time management can either agree or disagree with the items and can offer possible
corrective actions to be taken. Management may also respond to the district office in
writing after it has had sufficient time to properly study the FDA-483.
