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The FDA inspects facilities to ensure compliance with the Food, Drug and Cosmetic Act (FD&C Act) and can seek criminal or civil penalties against both companies and individuals when its regulations are violated. Intentionally defrauding or misleading the FDA or violating the act may be a felony, but the concept of strict liability means that even those who unintentionally violate the act can be prosecuted for misdemeanors because intent is not required to violate the law. Misdemeanor violations may result in fines of up to $1,000 and up to 1 year in prison. But criminal prosecutions are relatively rare because the various remedies at FDA's disposal, such as recalls and seizures, and the bad publicity that violations of the Act can generate and the desire of most companies to comply with FDA regulations are sufficient to ensure, if not complete compliance with FDA requirements, at least an honest effort by the vast majority of companies and individuals working in FDA-regulated industries.

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14y ago
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6mo ago

FDA inspections are important for ensuring the safety and quality of food, drugs, medical devices, and other regulated products. These inspections help identify and prevent potential risks and violations that could harm public health. By holding manufacturers and facilities accountable to regulatory standards, FDA inspections play a crucial role in maintaining consumer trust and confidence in the products they use.

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Q: What is the importance of FDA inspection?
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