FDA WARNING_LETTER - Tismor Health and Wellness Pty Limited - May 24, 2019

This FDA Warning Letter, dated December 5, 2019, was issued to Tismor Health and Wellness Pty Limited following an inspection from May 20-24, 2019. The letter identifies significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products, including "Thursday Plantation Tea Tree Antiseptic Cream," adulterated.

Key violations include: 1. **Data Integrity Issues (21 CFR 211.68(b)):** The firm failed to control computer systems adequately. Analysts had administrative privileges on the gas chromatography (GC) instrument's Empower software, leading to over 100 deleted test results and aborted sample sets since October 2017 without investigation. The firm's response, attributing issues to lack of training and audit trail review, was deemed inadequate for allowing "trial work" and not assessing the impact on all U.S.-distributed batches. 2. **Lack of Process Control Procedures (21 CFR 211.100(a)):** The firm failed to establish written procedures for production and process control. Equipment used in manufacturing was not qualified, and critical parameters like pump speed were not recorded in batch records or assured to be accurate. The firm's commitment to qualify equipment was deemed insufficient for not assessing the impact on previously distributed batches. 3. **Inadequate Laboratory Controls (21 CFR