FDA査察における評価

FDA Form 483

FDA査察が実施された場合、最終日の終わりにクローズアウトミーティングが開催される。
指摘事項が何もない場合は良いが、指摘事項がある場合は、連邦食品医薬品化粧品法704(b)項「査察官は指摘事項を文書で製造所に提示すること」に基づいて、査察のクローズアウトミーティング時に、FDA Form 483が発行される。
クローズアウトミーティングは、査察官の誤解や説明の間違いを正す機会でもある。
企業の意見を査察官が考慮し、FDA Form 483の最終版を作成してくれるので、すでに改善した事項があれば説明すると良い。
FDA Form 483には「最終的な評価はFDAコンプライアンス部門で実施されるので、FDA Form 483は査察時の指摘事項としての報告である。」と記載されている。

FDA査察の評価

査察における評価は、以下の3種類がある。

NAI:No Action Indicated(措置指示無し)
   指摘事項なし
VAI:Voluntary Action Indicated(自主的措置指示)
   指摘はあったが、行政からは何の措置もない
OAI:Official Action Indicated(強制措置指示)
   重大な指摘があり、行政措置がとられる。

NAIの場合は、FDA Form 483は発行されない。
FDA Form 483を発行する場合、査察結果は最低でもVAIに分類される。
査察を通じて見つけた所見がFDA Form 483に記載するほど重要な逸脱であった、または重要ではないが発生頻度の高い事象であったという意味である。
査察官は、回答の送付先や回答期限を説明してくれる。
OAIの場合は、査察時の指摘が重要かつ複合的であり、製品品質の欠陥につながる可能性がある場合に該当する。
OAIの場合は、FDA Form 483はその場では発行されず、後日送付されてくる。

FDA査察後の対応

FDAは、2009年8月11日付Federal Register(FR:連邦広報)において、
「Warning Letterを発行する前に、FDA Form 483へ回答するために、15作業日の猶予を与える。」
と発表している。

改善策、スケジュールを盛り込んだFDA Form 483に対する回答を15作業日以内(必着)にFDA本部へ送らなければならない。
査察の結果がVAIであったとしても、FDA Form 483の回答が不十分であれば、Warning Letterが発行されることになる。
FDA Form 483による指摘へのレスポンスは極めて詳細である必要はない。
レスポンスは査察を実施した査察官宛に送付するのではなく、FDA本部に送付することに注意が必要である。

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