A. Nelson & Co. Ltd.
FDA issued a warning letter to A. Nelson & Co. Ltd., a London-based homeopathic drug manufacturer, following an unannounced inspection in September 2025. The agency found significant CGMP violations including failure to conduct adequate microbial testing on each batch before release (including products for children as young as two), extending expiration dates without adequate stability data, and serious data integrity failures involving improper disposal of quality records and uninvestigated out-of-trend results. FDA warned that continued non-compliance could result in refusal of admission of the firm's products into the United States and withholding of approval for new applications.
Required actions (4)
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
FDA may withhold approval of new applications or supplements listing your firm as a manufacturer until any violations are completely addressed and we confirm your compliance with CGMP.
Failure to address any violations may also result in the FDA refusing admission of articles manufactured at A. Nelson & Co., Ltd., FEI 1000568184, at 5 Endeavour Way, London, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).
Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of your CAPAs before you pursue resolution of your firm's compliance status with FDA.
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