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Warning Letter 320-26-46

February 12, 2026

Dear Mr. Lockett:

The United States Food and Drug Administration (FDA) conducted an unannounced inspection of your drug manufacturing facility, A. Nelson & Co., Ltd., FEI 1000568184, at 5 Endeavour Way, London, from September 15 to 19, 2025.

This warning letter summarizes significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals. See Title 21 Code of Federal Regulations (CFR), parts 210 and 211 (21 CFR parts 210 and 211).

Because your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your drug products are adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).

We reviewed your October 9, 2025, response to our Form FDA 483 in detail and acknowledge receipt of your subsequent correspondence.

During our inspection, our investigators observed specific violations including, but not limited to, the following.

1. Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(b)).

You manufacture homeopathic drug products including those labeled for children as young as two years old.

You released drug products, including (b)(4) ml (batch (b)(4)) and (b)(4) (batch (b)(4)) without adequate testing for critical microbial attributes (e.g., total microbial count, absence of objectionable microorganisms).

Rather than testing every batch, you conducted (b)(4) tests on some of your batches of homeopathic drug products. Moreover, you did not conduct microbial testing before release for your (b)(4) drug products.

Furthermore, you extended expiration dates for (b)(4) drug product without adequate stability data to support these changes. For example, you extended the shelf life of (b)(4) ml (batch (b)(4)) from (b)(4), despite your stability data only supporting a (b)(4) month shelf life. Similar practices were also observed with other products.

In your response, you state that you implemented microbial testing for each bulk batch of (b)(4) drug products, each finished batch of (b)(4) drug products before release to the U.S., and the bulk (b)(4) component used in your drug products. You also commit to preparing a risk assessment to determine your microbial testing strategy covering all U.S. marketed products as well as a retrospective evaluation of all (b)(4) drug products shipped to the U.S. since September 2022 and September 2023, respectively.

We also acknowledge that you will reject the (b)(4) ml (batch (b)(4)). However, your response is inadequate because you did not commit to testing your retain samples for drug products that you released without adequate microbial testing.

Of particular note, your drug product (b)(4) (batch (b)(4)) was detained and refused admission at the U.S. border because FDA testing found microbiological contamination.

Without testing each batch prior to release, you did not have scientific evidence that all (b)(4) drug product batches were free of objectionable microbial contamination.

In response to this letter, provide:

• A list of chemical and microbial specifications, including test methods, used to analyze each batch of your drug products before a batch disposition decision.
  o An action plan and timelines for conducting full chemical and microbiological testing of retain samples to determine the quality of all batches of drug product distributed to the United States that are within expiry as of the date of this letter.
  o A summary of all results obtained from testing retain samples from each batch. If such testing reveals substandard quality drug products, take rapid corrective actions, such as notifying customers and product recalls.

2. Your firm failed to establish adequate written responsibilities and procedures applicable to the quality control unit and to follow written procedures applicable to the quality control unit (21 CFR 211.22(d)).

Your quality unit (QU) failed to provide adequate oversight and to ensure the reliability of data related to the quality of finished drug products manufactured at your facility. For example, you inadequately retained and disposed of CGMP documentation including manufacturing records printed and signed by your QU as well as finished product specifications forms. Notably, a handwritten sticky note indicating an “out-of-trend” result with a quality determination was discovered among the discarded materials, yet this deviation was neither properly documented at the time of performance nor adequately investigated.

You printed duplicate copies of records without an adequate procedure for the QU to track the issuance and reconciliation of CGMP documents. Furthermore, numerous analytical forms with unacceptable results were discarded that should have triggered investigations. These deficiencies raise significant data integrity concerns as critical quality records were improperly discarded.

In your response, you state that you completed the data integrity investigation with appropriate corrective action and preventive action (CAPA). You also state that following implementation of your CAPA, you will engage an external quality consultant to perform a site data integrity audit to review processes and compliance.

Your response did not commit to implementing adequate resources for the QU for tracking the issuance and reconciliation for CGMP documentation. Additionally, your external site data integrity audit is not scheduled until May 2026, which is an excessive delay given the extent of the data integrity violations observed. Further, your consultant engagement is intended as an audit of your corrections rather than a gap analysis providing guidance for adequate remediation. The delay in independent verification, combined with your corrective actions proceeding for eight months without external oversight, fails to provide adequate assurance that the systemic data integrity deficiencies will be adequately addressed in a timely manner.

Data integrity is critical throughout the CGMP data life cycle, including in the creation, modification, processing, maintenance, archival, retrieval, transmission, and disposition of data after the record retention period ends.

Your firm’s quality systems are inadequate. See FDA’s guidance document Quality Systems Approach to Pharmaceutical CGMP Regulations for help implementing quality systems and risk management approaches to meet the requirements of CGMP regulations 21 CFR, parts 210 and 211 at https://www.fda.gov/media/71023/download.

In response to this letter, provide:

• A comprehensive assessment and remediation plan to ensure your QU is given the authority and resources to effectively function. The assessment should also include, but not be limited to:
  o A determination of whether procedures used by your firm are robust and appropriate.
  o Provisions for QU oversight throughout your operations to evaluate adherence to appropriate practices.
  o A complete and final review of each batch and its related information before the QU disposition decision.
  o Oversight and approval of investigations and discharging of all other QU duties to ensure identity, strength, quality, and purity of all products.

Data Integrity Remediation

Your quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs you manufacture. See FDA’s guidance document Data Integrity and Compliance With Drug CGMP: Questions and Answers for guidance on establishing and following CGMP compliant data integrity practices at https://www.fda.gov/media/119267/download.

We acknowledge that you are using an independent third-party consultant to audit your operation and assist in meeting FDA requirements. In response to this letter, provide:

• A comprehensive investigation into the extent of the inaccuracies in data records and reporting including results of the data review for drugs distributed to the United States. Include a detailed description of the scope and root causes of your data integrity lapses.
• A current risk assessment of the potential effects of the observed failures on the quality of your drugs. Your assessment should include analyses of the risks to patients caused by the release of drugs affected by a lapse of data integrity and analyses of the risks posed by ongoing operations.
• A management strategy for your firm that includes the details of your global corrective action and preventive action plan. The detailed corrective action plan should describe how you intend to ensure the reliability and completeness of all data generated by your firm including microbiological and analytical data, manufacturing records, and all data submitted to FDA.

CGMP Consultant Recommended

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.

Your use of a consultant does not relieve your firm’s obligation to comply with CGMP. Your firm’s executive management remains responsible for resolving all deficiencies and systemic flaws to ensure ongoing CGMP compliance.

Additional API CGMP Guidance

You manufacture homeopathic active pharmaceutical ingredients (API, also known as (b)(4)) that you use in your finished drug products.

FDA considers the expectations outlined in ICH Q7 when determining whether API are manufactured in conformance with CGMP. See FDA’s guidance document Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients for guidance regarding CGMP for the manufacture of API at https://www.fda.gov/media/71518/download.

Conclusion
The violations cited in this letter are not intended to be an all-inclusive list of violations that exist at your facility. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations.

Correct any violations promptly. 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. We may re-inspect to verify that you have completed corrective actions to any violations.

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). Articles under this authority that appear to be adulterated may be detained or refused admission, in that the methods and controls used in their manufacture do not appear to conform to CGMP within the meaning of section 501(a)(2)(B) of the FD&C Act, 21 U.S.C. 351(a)(2)(B).

This letter notifies you of our findings and provides you an opportunity to address the above deficiencies. 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. In response to this letter, you may provide additional information for our consideration as we continue to assess your activities and practices. If you cannot complete corrective actions within 15 working days, state your reasons for delay and your schedule for completion.

Send your electronic reply to CDER-OC-OMQ-Communications@fda.hhs.gov. Identify your response with FEI 1000568184 and ATTN: Michael Klapal.

Sincerely,
/S/

Francis Godwin
Director
Office of Manufacturing Quality
Office of Compliance
Center for Drug Evaluation and Research