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The Price of Failure of Non-Compliance with FDA Part 210

The Food and Drug Administration (FDA) is a federal agency that is responsible for protecting the public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, dietary supplements, and products that give off electronic radiation.

FDA Part 210 is a set of regulations that establish the minimum requirements for current good manufacturing practice (cGMP) for finished pharmaceuticals. These regulations are designed to ensure that drugs are manufactured in a sanitary and controlled environment, and that they meet the quality standards established by the FDA.

Non-compliance with FDA Part 210 can have severe consequences for both the company and the public. For the company, non-compliance can result in:

  • FDA warning letters

  • FDA product seizures

  • FDA injunctions

  • FDA fines

  • Civil lawsuits

  • Criminal prosecution

For the public, non-compliance with FDA Part 210 can result in:

  • Injuries

  • Illnesses

  • Deaths

In some cases, non-compliance with FDA Part 210 has even led to the recall of entire drug classes. For example, in 2008, the FDA recalled all ranitidine products (a common heartburn medication) due to contamination with a known carcinogen. The recall was the result of non-compliance with FDA Part 210 by several drug manufacturers.

Companies that manufacture drugs must take FDA Part 210 seriously. By following these regulations, companies can help to ensure the safety and efficacy of their products, and protect the public health.

Here are some tips for companies to help ensure compliance with FDA Part 210:

  • Contact a reliable and experienced consulting firm to help you with your FDA compliance needs.

  • Develop and implement a comprehensive cGMP program.

  • Train employees on cGMP requirements.

  • Conduct regular audits to ensure compliance.

  • Document all cGMP activities.

  • Report any violations to the FDA immediately.

By following these tips, companies can help to protect the public health and avoid the severe consequences of non-compliance with FDA Part 210.

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