Tismor Health and Wellness Pty Limited – FDA 483, May 24, 2019

An FDA inspection of Tismor Health and Wellness Pty Limited, an OTC drug product manufacturer in Kingsgrove, Australia, revealed significant deficiencies across its quality system. The firm failed to adhere to quality control unit procedures for batch release, exhibited poor laboratory control practices including data integrity issues, and lacked appropriate controls over computer systems and manufacturing processes. These findings indicate a lack of assurance in product quality and data reliability for products destined for the U.S. market.