FDA査察が実施された場合、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（FDC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、査察の最後の講評時に、FDA Form 483が発行される。
483は一般には公開されない。 ただし情報公開法に基づき、有償で公開請求はできる。 またWarning Letterで483の内容に言及することが多い。 講評時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。 誤解や説明の間違いを正す機会でもある。
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 Form 483フォームの調べ方
Warning LetterはFDAのホームページで公開されますが、483 Formは公開されません。
しかしながら、米国の情報公開法に基づき、有償で取り寄せることも可能です。
一部の483 Formは、サイトから購入することができます。
FDA Form 483を受取ったら
FDA Form 483により指摘された内容に対し、15営業日以内（必着）にレスポンスを送付すること。
早急な回答により、FDAは、企業がその期待を理解し、483を重大なことと受け止めていることを理解する。
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。
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作業日以内にFDAへ送ること。
次回査察時に改善実施について確認されるので、確実に改善ができることを書くこと。
机上の空論のようなことは書かないこと。
FDA Form 483の回答が不十分であれば、Warning Letterをもらうことになる。
FDA Form 483にはならなかったが、他に指摘点があれば、原因の究明、再発防止に手段を講じること。
後日FDAより送付されてくるEstablishment Inspection Report（EIR）の内容を確認すること。
FDA Form 483にはない詳しい情報が含まれている。
FDA査察の指摘事項（FDA Form 483）への回答期限について
FDAは、2009年8月発表のFederal Registerで、
「FDA査察の指摘事項（FDA Form 483）への回答期限を15日以内とする。Warning Letterを速やかに出せるようにするためである。2009年9月15日から実施する。」
と通知した。
FDA査察官がFDA Form 483を発行した場合、改善策、スケジュールを盛り込んだ回答を15日以内にFDA必着で郵送しなければならない。
理由の如何を問わず、FDA Form 483への回答が15日以内にFDAに届かない場合は、Warning Letterが発行されることになる。
日本企業においても、過去に15日以内に指摘事項への回答が15日以内にFDAに届かなかったため、Warning Letterが発行された企業が数社見受けられる。
また、FDA Form 483の回答が不十分であったり、不適切であると判断された場合も、Warning Letterが発行される。
あるデンマークの企業は、改訂したSOPをデンマーク語でFDAに送付したために、Warning Letterが発行された。
FDAは「デンマーク語でレビュできないためである」ということであった。
別のドイツの企業は、FDA査察官の指摘事項をデータベース化し、改善状況をオンラインでFDAがレビュできるようにした。
FDAにアカウント情報を通知したところ「我々はあなたの企業のシステムにログオンするつもりはない。」といったWarning Letterが発行された。
回答書は、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。
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。
つまり査察官によっては、専門分野や考え方などから、指摘事項が企業毎に異なることが多く、不公平が生じるため、FDA本部が指摘事項を見直すのである。
筆者がコンサルテーションを実施した企業においても、査察官が指摘を9件発行したが、後にFDA本部が指摘ゼロに変更した事例がある。
しかしながら、15日以内にはFDA本部の最終決定は出ないため、いずれにせよ査察官の指摘に対応せざるを得ない。
FDA Form 483による指摘への回答は極めて詳細である必要はない。
次回査察時に回答書に記載した改善実施について確認されるので、確実に改善ができることを書くこと。机上の空論のようなことは書いてはならない。
また後日（かなり時間がかかるが）Establishment Inspection Report（EIR）がFDAから送られてくる。EIRは、査察官の議事録のようなもので、FDA Form 483にはない詳しい情報が含まれている。
次回査察時における参考になる。
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