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。
FDAの長官は大統領が任命する。2009年にオバマ政権になってからは、Warning Letterの発行を即座に行うよう方針転換がなされた。
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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