Responding to an FDA Form 483:A Five-Step Approach

摘要

:When the US Food and Drug Administration (FDA) inspects your company's biomanufacturing facility,investigators use the FDA Form 483 to record observations and findings (l). Such inspections typically review all good manufacturing practices and good laboratory practices (GxP) quality systems documents. If those investigators find compliance issues, they deliver a summary of their observations and findings using a Form 483, a copy of which will be provided to your company at the end of the inspection visit.