FDA Form 483：回答と警告書

Form 483: what happens next? It lists what investigators observed during your inspection, not a final FDA decision. But your written answer, and how fast it arrives, shapes what FDA does. Speed matters. FDA's device inspection program asks manufacturers to send corrections and a corrective action plan in writing within 15 business days after the inspection closes. If a warning letter follows, it usually asks for a written reply within 15 working days. FDA judges the content, not just the speed. It looks for a corrective action plan with depth, scope and a timeline, a retrospective review across your quality system, evidence of fixes already made, and regular progress updates. Then FDA classifies the inspection: no action, voluntary action, or official action indicated. That decision rests on what the investigators found and on your response, including any corrective actions. Start with three things. One: answer every observation, point by point. Two: attach evidence, not just promises. Three: keep sending updates until each action is closed. Answer fast, and prove every fix. Pure Global covers registration, in-country representation, quality systems, audits and cybersecurity, in more than 30 markets. Visit pureglobal.com.