Miers Laboratories, Ltd
FDA issued a warning letter to Miers Laboratories, Ltd (New Zealand) following a May 2025 inspection that found significant CGMP violations in the manufacture of homeopathic drug products intended for the U.S. market. Key violations included failure to perform identity testing on incoming components — including a solvent with potentially lethal contamination — and use of an active pharmaceutical ingredient more than 14 years past expiration, as well as inadequate quality unit oversight. These are repeat violations from 2014 and 2019 inspections; FDA has placed all drugs from this firm on Import Alert 66-40, effectively blocking U.S. importation.
Required actions (4)
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.
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.
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.
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.
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