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Wuxi Medical Instrument Factory Co., Ltd. was cited for manufacturing drug products under insanitary conditions that may have become contaminated or rendered injurious to health, constituting violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals under 21 CFR parts 210 and 211. The company's December 2024 response to FDA inspection findings was deemed inadequate, as it failed to provide evidence of corrective actions and notably acknowledged lacking the ability to manufacture sterile drug products in compliance with FDA requirements. The facility's admission that it does not produce sterilized pharmaceutical products as required despite labeling them as such presented a significant public health risk to patients relying on these medications.