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FORM 27I: Regulatory Notification for Final Significance Determination (with White, Yellow, or Red Finding) and No Notice of Violation(Date)RN YYXXXOFFICEOFENFORCEMENTNOTIFICATIONOFSIGNIFICANTREGULATORYACTIONLicensee:(Name
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The FDA Form 483 is a form used by the FDA to document and communicate violations found during inspections of facilities regulated by the FDA.
Any facility regulated by the FDA that undergoes an FDA inspection and is found to have violations must file the FDA Form 483.
The form must be filled out by the FDA inspector conducting the inspection and must detail the violations found during the inspection.
The purpose of the FDA Form 483 is to inform the facility of the violations found during the inspection and to give them an opportunity to respond to the findings.
The form must include details of the violations found during the inspection, as well as any responses or corrective actions taken by the facility.
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