FDA 483 - A. Nelson & Co., Ltd. - September 19, 2025

A. Nelson & Co., Ltd., a manufacturer of API and homeopathic drug products in London, Great Britain, was cited for significant deficiencies across its quality system during an FDA inspection. The observations highlight severe issues including inadequate microbial testing for homeopathic products, a systemic failure in conducting comprehensive investigations and implementing effective corrective actions, poor document control practices, and insufficient production and process controls. These deficiencies indicate a lack of control over product quality and safety.