FDA Inspection Letter

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    • April 8, 2020 at 7:51 pm #3048
      Sandra Pacheco
      Participant

      Dear all,

      Where would you file the FDA Inspection Letter.

      Thanks so much!

    • April 9, 2020 at 1:45 pm #3050
      Eldin Rammell
      Participant

      In my experience, this is typically not part of the TMF. It is part of the Quality Management System / Audit files.

    • April 9, 2020 at 4:52 pm #3051
      Sandra Pacheco
      Participant

      Perfect, thanks so much Eldin

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