FDA WARNING_LETTER - Miers Laboratories Ltd. - May 21, 2025

The FDA issued a Warning Letter to Miers Laboratories, Ltd following an inspection from May 19 to 21, 2025, for significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals (21 CFR parts 210 and 211). Consequently, the company"s drug products are considered adulterated. Key issues identified included a critical failure to perform adequate identity testing on incoming drug components. Miers Laboratories relied solely on supplier certificates of analysis without proper validation, leading to the use of a solvent (propylene glycol) contaminated with unacceptable levels of ethylene glycol, a substance known for its lethal toxicity. The company also utilized homeopathic active ingredients that were over 14 years past their expiration without retesting. These component control deficiencies represent a repeat violation from a 2019 inspection. Furthermore, the quality control unit failed to provide sufficient oversight for manufacturing operations. This involved not maintaining appropriate batch production records and lacking established written procedures for managing quality functions like deviations and corrective actions, both of which are repeat violations from previous inspections (2014 and 2019). The FDA mandates a comprehensive review and remediation plan for the company"s material systems, including robust supplier qualification and incoming material testing, especially for potential contaminants like ethylene glycol in distributed products. A thorough assessment and enhancement of the Quality Control Unit"s authority, resources, and procedures are also required. Due to persistent repeat violations, the FDA strongly recommends engaging a qualified CGMP consultant to ensure compliance.