It’s not just the temperatures that have been sizzling as of late! FDA’s recent flurry of FSVP Warning Letters continues to demonstrate that FSVP enforcement is hot, and high!
As a reminder, FSVP mandates that importers verify that their foreign suppliers meet U.S. safety standards. We will take a look here at the top five violations noted in FDA’s latest communications:
1. Failure to Develop an FSVP
One of the most frequent violations cited by the FDA is the complete absence of an FSVP.
Many importers fail to develop or implement any verification program for their foreign suppliers. This oversight is critical as it forms the foundation of ensuring that imported food meets U.S. safety standards. The FSVP requires a documented program outlining procedures for evaluating and approving foreign suppliers, along with actions to verify that the food they provide is produced in accordance with applicable safety regulations.
Example Violation:
The FDA found that a company did not have an FSVP for multiple food products, thereby violating Section 805 of the Federal Food, Drug, and Cosmetic Act (FDCA).
2. Inadequate Hazard Analysis
Another common issue is the failure to conduct a comprehensive hazard analysis for imported foods. Importers must identify and evaluate known or reasonably foreseeable hazards associated with each food product. This analysis is critical in determining the necessary control measures to ensure food safety.
Example Violation:
The FDA reported that a company’s hazard analysis was either not performed or was incomplete, failing to address significant risks such as microbial contamination or chemical hazards in their imported spices.
3. Lack of Supplier Verification Activities
Even when an FSVP exists, some companies fail to perform adequate supplier verification activities. These activities can include audits, sampling and testing, or reviewing the supplier’s relevant food safety records. Without these verification actions, there is no assurance that the foreign supplier consistently produces food that meets U.S. safety standards.
Example Violation:
The FDA found that a company did not conduct any verification activities for its foreign suppliers of ready-to-eat foods, posing potential risks of contamination and non-compliance with food safety requirements.
4. Failure to Take Corrective Actions
When issues are identified, it is crucial for importers to take prompt and effective corrective actions. However, many warning letters highlight the failure to address identified problems adequately. This could involve not responding to identified hazards or not implementing sufficient measures to prevent recurrence.
Example Violation:
The FDA noted that after identifying contamination issues with imported seafood, a company failed to take necessary corrective actions, such as enhancing supplier audits or increasing product testing frequency.
5. Inadequate Documentation and Record-Keeping
Proper documentation and record-keeping are essential components of the FSVP. Importers must maintain detailed records of their verification activities, hazard analyses, and corrective actions. Inadequate documentation can lead to gaps in ensuring food safety and regulatory compliance.
Example Violation:
Company B: The FDA found that a company’s records were incomplete and disorganized, with missing documentation for supplier evaluations and hazard analyses, making it difficult to verify compliance with FSVP requirements.
The FDA’s recent (and toasty!) warning letters serve as a critical reminder that make no mistake about it –FSVP is being enforced! In addressing these common Warning Letter violations—developing comprehensive FSVPs, conducting thorough hazard analyses, performing robust supplier verification activities, taking effective corrective actions, and maintaining adequate documentation—importers can better ensure the safety of the food they bring into the U.S. market and compliance with the U.S. FDA.
For more information on FSVP compliance, including preparing for an FSVP inspection, developing an FSVP Program, responding to an FDA 483 or Warning Letter and more, please contact us at info@garg-law.com.
