Les Importations Herbasante Inc. – FDA Warning Letter, Aug 18, 2023

The FDA inspected Les Importations Herbasanté Inc. from August 14-18, 2023, identifying significant Current Good Manufacturing Practice (CGMP) violations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Failure to test components (21 CFR 211.84):** The firm did not adequately test glycerin, a high-risk component for diethylene glycol (DEG) and ethylene glycol (EG) contamination, used in pediatric products. They also failed to perform identity testing for (b)(4) and (b)(4), relying on supplier Certificates of Analysis (COAs) without validation. The response regarding retrospective and future testing was deemed inadequate. 2. **Inadequate production and process controls (21 CFR 211.100(a)):** The firm failed to validate manufacturing processes for homeopathic drug products, including those for infants and children. Their proposal for manual (b)(4) was considered inadequate due to inherent variability. 3. **Quality Control Unit (QU) failures (21 CFR 211.22):** The QU did not ensure CGMP compliance, failing to oversee procedures, provide oversight, conduct final batch reviews, or approve investigations.

These are repeat violations, indicating inadequate executive management oversight. As a