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Strukmyer Medical, a drug manufacturer in Mesquite, Texas, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals during an FDA inspection from July-August 2024. The company failed to adequately investigate over 60 instances of objectionable microorganisms—including Burkholderia, Pseudomonas, Staphylococcus, Bacillus, and Aspergillus species—isolated from its water system used as a component in over-the-counter wound and burn care products, and did not implement sufficient corrective actions to prevent recurrence. These manufacturing control failures rendered the drug products adulterated under the Federal Food, Drug, and Cosmetic Act.