Miers Laboratories, Ltd

Warning LetterOpen

Mr. Andrew Criglington Chief Executive Officer Miers Laboratories, Ltd 32 Waiu Street, Wainuiomata Lower Hutt Wellington 5014 New Zealand ac@mierslabs.co.nzFEI 3004087508Issued Nov 3, 2025Center for Drug Evaluation and Research (CDER)

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3004087508.

Violations3

Issue DateNov 3, 2025

Product TypeDrugs

StatusOpen

Letter Details

Firm: Miers Laboratories, Ltd
Location: Mr. Andrew Criglington Chief Executive Officer Miers Laboratories, Ltd 32 Waiu Street, Wainuiomata Lower Hutt Wellington 5014 New Zealand ac@mierslabs.co.nz
FEI Number: 3004087508
Country: New Zealand
Issue Date: November 03, 2025
Issuing Office: Center for Drug Evaluation and Research (CDER)
Product Type: Drugs
Status: Open

Summary

Miers Laboratories, Ltd, a New Zealand-based drug manufacturer, was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of homeopathic drug products. The FDA inspection (May 19-21, 2025) identified critical failures in component testing and supplier validation, including the company's reliance on suppliers' certificates of analysis without establishing the reliability of those analyses at appropriate intervals, and its failure to conduct identity testing on incoming components used in manufacturing. Notably, the firm used untested material containing an undisclosed percentage of an unspecified substance as a solvent for homeopathic tablets, resulting in numerous drug products being manufactured without adequate identity verification. These CGMP violations rendered the firm's drug products adulterated under the Federal Food, Drug, and Cosmetic Act.

Miers Laboratories, Ltd FDA Warning Letter, November 3, 2025