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The agency said the company failed to meet CGMP requirements, including implementing and adhering to its risk-based corrective and preventive action (CAPA) procedures

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OS can be triggered by free radicals or other oxidant species produced by either exogenous processes (environmental pollutants, drugs, viruses, bacteria, ionizing radiations, heavy metals, poor diet, and smoking) [3,4,5,6,7,8,9,10,11] or endogenous processes (such as immune cell activation, inflammation, ischemia, infection, cancer, and aging) [12,13,14,15,16,17,18,19]