FDA WARNING_LETTER - Medinatura New Mexico, inc. - May 23, 2025

The FDA issued a Warning Letter to Medinatura New Mexico, Inc. following an inspection conducted from May 19 to May 23, 2025. The letter outlined significant breaches of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals, indicating that the company"s drug products do not meet quality standards. A primary violation involved the failure to adequately test incoming components for identity, purity, strength, and quality. Specifically, Medinatura failed to properly test an active pharmaceutical ingredient, (b)(4), for potential contamination with (b)(4), a substance known to cause lethal poisoning incidents. The firm also relied on supplier certificates of analysis without validating their reliability. Another critical issue was the absence of adequate written procedures for cleaning and maintaining manufacturing equipment. The lack of proper cleaning validation and documentation for non-dedicated equipment created a risk of cross-contamination between different drug products. The FDA requires Medinatura to promptly provide test results for high-risk components or finished products for (b)(4) contamination, conduct a comprehensive risk assessment for all in-expiry drugs, and implement corrective actions, including potential product recalls. The company must also describe how it will ensure rigorous testing of all incoming raw materials and validate supplier data. For the cleaning deficiencies, a comprehensive, independent assessment of cleaning effectiveness is mandated, along with a corrective and preventive action plan to prevent future cross-contamination.