Analysis and Case Study Review: FDA Warning Letter To Tismor Health and Wellness

Abstract

This article provides a breakdown of an interesting US FDA Warning Letter. This Warning Letter is an excellent example of the remediation activities required by the US FDA when inefficiencies are found around access authorization. On 5 December 2019, the US FDA issued a Warning Letter (320-20-10) to the Australian firm Tismor Health and Wellness Pty Limited, following an inspection conducted on May 20 to 24, 2019.