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What is the penalty of non-compliance for FSVP?

The penalties for non-compliance with the Foreign Supplier Verification Program (FSVP) can vary depending on the severity of the violation, the associated risks to public health, and the discretion of the regulatory authorities. The U.S. Food and Drug Administration (FDA) is responsible for enforcing FSVP regulations and may take enforcement actions when violations are identified. Here are some potential penalties or consequences for non-compliance:

  1. Warning Letters: The FDA may issue a warning letter to the responsible party, such as the importer or FSVP agent, notifying them of the violations and requesting corrective actions. Warning letters serve as an official notice and indicate that further enforcement actions may be taken if the violations are not addressed.

  2. Import Refusals and Detentions: If the FDA determines that a food product does not comply with FSVP requirements, it can refuse entry of the product into the United States or detain it at the port of entry. The food may be held until the responsible party demonstrates compliance or takes appropriate corrective actions.

  3. Seizures and Recalls: In serious cases where there is evidence of significant health risks associated with non-compliant food products, the FDA may initiate seizure actions to remove the products from the market. The FDA can also request voluntary recalls or order mandatory recalls to protect public health and safety.

  4. Civil Monetary Penalties: The FDA has the authority to impose civil monetary penalties on individuals or companies that violate FSVP regulations. These penalties can vary in amount depending on the specific violation, ranging from thousands to millions of dollars.

  5. Criminal Prosecution: In cases of intentional or willful violations that pose a serious threat to public health, the FDA may pursue criminal charges. Criminal prosecution can result in fines, imprisonment, or both for individuals found guilty of FSVP-related offenses.

It's important to note that the FDA's enforcement actions are intended to ensure compliance with FSVP requirements, protect public health, and promote food safety. The specific penalties imposed will depend on the circumstances of each case. To avoid penalties and ensure compliance, importers and FSVP agents should establish and maintain robust FSVP programs, conduct thorough supplier verification, and keep accurate and complete records of their FSVP activities.

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