1. NAI(No Action Indicated)
  2. VAI(Voluntary Action Indicated)
  3. OAI(Official Action Indicated)である。

    NAIは、公式にFDA Form 483による指摘がないことを意味する、査察結果としては最高である。
    VAIは、重大な規制要件違反は見つからなかったが、自主的な改善が要求され、FDA Form 483が発行される。
    OAIは、重大な規制要件違反が発見され、FDA Form 483が発行されたうえで、即座にFDA本部からWarning Letterが発行される。

ちなみにFDA Form 483は、文書に署名した上で企業に提供することが義務付けられている。

場合によっては、査察官がFDA Form 483を電子データで企業に手渡し、クローズアウトミーティング後に最終版を作成したのち、電子署名を付す場合もある。

FDA査察官は、過去のエラーに対して指摘を出すのではなく、今後のリスクに対して指摘を出すわけなので、改善済の事項については、FDA Form 483を発行しない場合が多いのである。




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