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

From September 15 to September 19, 2025, the U.S. Food and Drug Administration (FDA) inspected the manufacturing facility of A. Nelson & Co., Ltd. in London, Great Britain. The inspection identified several critical violations of the Federal Food, Drug, and Cosmetic Act regarding the production of homeopathic drug products. Key issues included a failure to perform necessary microbial testing on liquid products distributed to the U.S. market, which poses a potential risk to consumer safety. Additionally, the firm’s quality unit failed to conduct thorough investigations into manufacturing failures, often dismissing contamination issues as sampling errors without identifying root causes or implementing effective corrective actions. Significant concerns were also raised regarding document control, as sensitive manufacturing records were discovered in unsecured trash bins and data was frequently recorded on unofficial notes. The firm also extended product expiration dates without supporting scientific data and failed to validate its packaging processes to prevent labeling errors and product mix-ups. Finally, investigations into consumer complaints regarding adverse reactions, such as burning sensations, were found to be insufficient or overdue. Under the current regulatory framework, these observations require the company to evaluate its quality systems and implement robust corrective measures. While this document is not a final determination of compliance, A. Nelson & Co., Ltd. is expected to respond with a detailed plan to address these systemic deficiencies and ensure the identity, strength, and purity of its products.