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FDA FSVP Inspections and Warning Letters on the Rise, oh my!

The Importance of Conducting a Regulatory “Check-Up”: Ensuring FSVP Compliance and Passing an FDA FSVP Inspection
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FDA plays a critical role in safeguarding public health by enforcing regulations to ensure the safety of imported food products via routine inspections and other means. Recently, the FDA issued three warning letters to food companies for their failure to have a Foreign Supplier Verification Program (FSVP) in place. Specifically, FDA found that all three firms were not in compliance with the requirements of Section 805 of the Federal Food, Drug and Cosmetic Act (FDCA) and the implementing FSVP regulations, as the companies failed to develop, maintain and follow an FSVP for any imported foods. While the Agency has not yet moved to place these companies on Import Alert, the FDA can place firms who are not in compliance with the FSVP regulations on Import Alert #99-41. Safe to say, a Warning Letter and/or placement on Import Alert is not a-peeling!

The Agency also determined that one company did not have a documented rationale supporting their “very small importer” designation and with that, the company did not have supporting documentation to confirm applicability of certain exemptions and/or modifications from the FSVP regulations. The FDA advised that notwithstanding, the Company failed to comply with relevant requirements for the imported foods including obtaining written assurances from the company’s foreign supplier. In the other two warning letter cases, FDA advised that as importers of covered produce, the importers failed to have an FSVP that demonstrated the supplier’s compliance with the produce safety rule.

The Agency’s issuance of these recent Warning Letters underscores the importance of compliance with FSVP regulations for companies involved in importing food into the United States. We will provide here a brief recap of FSVP, how your company can confirm compliance by conducting a “regulatory check-up,” and how to prep and pass an FDA FSVP Inspection!


Understanding FSVP

The FSVP rule, established under the FDA Food Safety Modernization Act (FSMA), requires importers to perform risk-based activities to verify that foreign suppliers meet applicable U.S. food safety standards. These standards aim to prevent food safety problems and ensure the safety of imported foods.


Compliance with FSVP

To comply with FSVP regulations, importers must:

  • Conduct a Hazard Analysis: Identify and evaluate the known or reasonably foreseeable hazards associated with each food imported.
  • Assess Foreign Supplier Compliance: Evaluate the foreign supplier’s compliance with applicable food safety regulations, including whether they have adequate preventive controls in place.
  • Develop FSVP Procedures: Establish and implement written procedures to ensure compliance with FSVP requirements, including monitoring, corrective actions, and verification activities.
  • Maintain Records: Keep records documenting compliance with FSVP regulations, including supplier verification activities and corrective actions taken.


Conducting a Mock FSVP Audit Inspection

To prepare for an FDA FSVP inspection, importers must turnip the beet. We recommend importers conduct mock FSVP audit inspections internally or with the assistance of regulatory counsel, what we like to call a “FSVP Regulatory Check-Up”. This includes:

  • Review FSVP Requirements: Ensure a thorough understanding of FSVP regulations and requirements applicable to your imported food products.
  • Identify Key Suppliers: Identify and prioritize key foreign suppliers for the mock audit based on factors such as volume, risk, and past compliance history.
  • Gather Documentation: Collect and review relevant documentation, including supplier agreements, hazard analyses, supplier verification records, and corrective action plans.
  • Perform Audit Activities: Conduct on-site or remote audits of selected foreign suppliers, focusing on areas such as supplier facility inspections, food safety practices, and documentation review.
  • Identify Non-Conformances: Document any non-conformances or deficiencies observed during the mock audit, including gaps in documentation, inadequate preventive controls, or supplier non-compliance with FSVP requirements.
  • Implement Corrective Actions: Develop and implement corrective actions to address identified non-conformances, including communication with suppliers, process improvements, and documentation updates.
  • Review and Update Procedures: Review FSVP procedures and documentation based on findings from the mock audit, ensuring continuous improvement and compliance readiness.
  • Develop procedures and best practices for navigating an FDA FSVP Inspection: Review what to do (and what to say/not to say!) before, during and after an FDA FSVP inspection.

To increase the likelihood of passing an FDA FSVP inspection, we recommend your Company (1) maintain accurate records, including keeping detailed and up-to-date records of all FSVP activities, supplier verification, monitoring, and corrective actions; (2) establish open communication channels with foreign suppliers to facilitate information exchange and address any concerns related to food safety and compliance; (3) provide training to employees responsible for FSVP compliance to ensure they understand their roles and responsibilities; (4) stay informed about changes to FSVP regulations and guidance documents issued by the FDA; and (5) conduct regular internal “mock” audits to identify and address potential compliance issues proactively.

Compliance with FSVP regulations is essential for importers to ensure the safety of imported food products and avoid FDA enforcement actions. By understanding FSVP requirements, conducting mock FSVP audit inspections, and implementing practical tips for passing FDA inspections, companies can demonstrate their commitment to food safety and regulatory compliance in the global food supply chain and grapefully avoid being the target of an FDA warning letter!


For assistance with U.S. FDA FSVP requirements including FSVP inspections, please contact us at info@garg-law.com.

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