Eksa Mills S.A. de C.V. Warning Letter Details

Summary

Eksa Mills S.A. de C.V., a Mexican pharmaceutical manufacturer, violated Current Good Manufacturing Practice (CGMP) regulations for finished drug products, rendering their over-the-counter drugs adulterated. FDA inspectors found that the facility failed to properly clean, maintain, and sanitize manufacturing equipment at appropriate intervals, creating cross-contamination risks since the same non-dedicated equipment was used to manufacture both OTC drug products and commercial chemical solutions for other industries. The company's response to FDA's initial inspection findings was deemed inadequate due to insufficient detail and lack of evidence demonstrating corrective actions necessary to achieve CGMP compliance.