Loading…
Miers Laboratories, Ltd, a New Zealand-based drug manufacturer, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of homeopathic drug products. The FDA inspection (May 19-21, 2025) identified critical failures in component testing and supplier validation, including the company's reliance on suppliers' certificates of analysis without establishing the reliability of those analyses at appropriate intervals, and its failure to conduct identity testing on incoming components used in manufacturing. Notably, the firm used untested material containing an undisclosed percentage of an unspecified substance as a solvent for homeopathic tablets, resulting in numerous drug products being manufactured without adequate identity verification. These CGMP violations rendered the firm's drug products adulterated under the Federal Food, Drug, and Cosmetic Act.