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

The FDA issued a Warning Letter to A. Nelson & Co. Ltd. following an inspection of its London drug manufacturing facility from September 15-19, 2025. The letter highlights significant violations of Current Good Manufacturing Practice (CGMP) regulations (21 CFR parts 210 and 211), rendering the company's drug products adulterated under the Federal Food, Drug, and Cosmetic Act.

Key issues include the failure to conduct appropriate laboratory testing for each batch of drug product, particularly regarding objectionable microorganisms in homeopathic products, some intended for children. The company released products without adequate microbial testing and extended expiration dates without sufficient stability data. Notably, one product was refused entry into the U.S. due to microbial contamination.

Additionally, the firm"s Quality Control Unit demonstrated a lack of adequate oversight, failing to ensure data reliability. Investigators found improper retention and disposal of critical CGMP documentation, including manufacturing records and analytical forms with unacceptable results, raising serious data integrity concerns.

The FDA requires A. Nelson & Co. Ltd. to provide a detailed action plan, including timelines for comprehensive chemical and microbiological testing of all distributed retain samples. The company must also submit a comprehensive assessment and remediation plan for its Quality Unit, ensuring its authority and resources are sufficient. A thorough data integrity remediation plan, including a root cause investigation and risk assessment, is mandated. The FDA strongly recommends engaging a qualified CGMP consultant to perform a comprehensive audit and ensure compliance before resolution of the firm’s status.