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Warning Letter 320-26-13

November 3, 2025

Dear Mr. Criglington:

The United States Food and Drug Administration (FDA) inspected your drug manufacturing facility, Miers Laboratories, Ltd, FEI 3004087508, at 32 Waiu Street, Wainuiomata, Lower Hutt, Wellington, from May 19 to 21, 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 have not yet received a response from your firm stating the actions you are taking to address the deficiencies identified during the inspection and cited on our Form FDA 483.

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

1. Your firm failed to conduct at least one test to verify the identity of each component of a drug product. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)).

You manufacture homeopathic drug products, several of which are intended for use in (b)(4). You failed to perform adequate identity testing on incoming components used in the manufacture of your homeopathic drug products. You solely relied on your suppliers’ certificates of analysis (COAs) without establishing the reliability of your component suppliers’ test analyses at appropriate intervals.

(b)(4)

You failed to perform identity testing on a batch of (b)(4) containing up to (b)(4)% (b)(4). You used this material as a solvent for (b)(4) tablets with homeopathic active pharmaceutical ingredients to manufacture numerous drug product batches for the U.S. market. The United States Pharmacopeia identity test for (b)(4) includes a (b)(4) limit of (b)(4) ppm. Your use of (b)(4) with (b)(4) is unacceptable.

You manufacture multiple drugs that contain (b)(4). The use of (b)(4) has resulted in various lethal poisoning incidents in humans worldwide. See (b)(4)

Homeopathic active pharmaceutical ingredients

You failed to perform adequate testing on homeopathic active pharmaceutical ingredients. For example, you used a batch of (b)(4) that was more than 14 years past its expiration to manufacture numerous batches of finished drug products without determining whether the component continued to meet quality attributes.

Without appropriate testing of incoming components, you cannot verify that the identity, purity, strength, quality, and safety of components meet specifications, and cannot confirm their suitability for intended use.

This is a repeat violation from your 2019 inspection.

In response to this letter, provide:

• A comprehensive review of your material system to determine whether all suppliers of components, containers, and closures, are each qualified and the materials are assigned appropriate expiration or retest dates. The review should also determine whether incoming material controls are adequate to prevent use of unsuitable components, containers, and closures.
• The chemical and microbiological quality control specifications you use to test and release each incoming lot of components for use in manufacturing.
• A description of how you will test each component lot for conformity with all appropriate specifications for identity, strength, quality, and purity. If you intend to accept any results from your suppliers’ COAs instead of testing each component lot for strength, quality, and purity, specify how you will robustly establish the reliability of your suppliers’ results through initial validation as well as periodic re-validation. In addition, include a commitment to always conduct at least one specific identity test for each incoming component lot.
• A summary of your program for qualifying and overseeing contract facilities that test the drug products you manufacture.
• A summary of results obtained from testing reserve samples of finished products on the U.S. market for (b)(4) content. If such testing identifies drug products with unacceptable (b)(4) levels, take rapid corrective actions such as notifying customers and product recalls.

2. Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).

During the inspection, our investigator observed that your quality unit (QU) did not provide adequate oversight for the manufacture of your homeopathic drug products. Your QU failed to ensure the following:

• Appropriate batch production and control records that include documentation of the accomplishment of each significant step in manufacturing of your drug products (21 CFR 211.188(b)). This is a repeat violation from your 2014 and 2019 inspections.
• Establishment of written procedures for managing quality unit functions including deviations, investigations, and corrective actions and preventive actions (21 CFR 211.22(d)). This is a repeat violation from you 2019 inspection.
• Establishment of an adequate quality control unit to approve or reject components and drug products (21 CFR 211.22(a)).

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/regulatory-information/search-fda-guidance-documents/quality-systems-approach-pharmaceutical-current-good-manufacturing-practice-regulations.

In response to this letter, provide the following:

• 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.

Repeat Violations at Facility

In a previous inspection, performed June 17 to 21, 2019, FDA cited similar CGMP observations. You acknowledged these observations and informed our investigators that you would correct all observations during the closeout meeting. Despite these commitments, when FDA reinspected your facility, the violations had not been corrected. Repeated failures demonstrate that executive management oversight and control over the manufacture of drugs is inadequate.

CGMP Consultant Recommended

Because you failed to correct repeat violations, you should engage a consultant qualified as set forth in 21 CFR 211.34 to assist your firm in meeting CGMP requirements.

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.

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.

FDA placed all drugs and drug products offered for import into the United States from your firm on Import Alert 66-40 on October 27, 2025.

Correct any violations promptly. FDA may withhold approval of new applications or supplements listing your firm as a drug 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 continuing to refuse admission of articles manufactured at Miers Laboratories, Ltd., at 32 Waiu Street, Wainuiomata, Lower Hutt, Wellington, 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 3004087508 and ATTN: Emily Wu.

Sincerely,
/S/

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