We have written before about FSVP being a serious issue, but it is clear that FDA is taking lack of compliance with FSVP very seriously. In December 2023, we wrote about the number of 483 citations issued by FDA during that year for noncompliance with FSMA’s Foreign Supplier Verification Program (FSVP) Rule, with the top citation being the failure to develop an FSVP. Unfortunately, 2024 isn’t looking much better with the agency having already issued 14 warning letters for FSVP violations. Remember – warning letters are only issued after a company has failed to either respond or provide adequate response/corrective action to a 483 issued for violations observed during an inspection, and the repercussions can be very serious.
The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food they import into the United States has been produced in a manner that meets applicable U.S. food safety standards. For example:
- One importer was issued a 483 for not providing a written hazard analysis or any FSVP records for fresh ginger imported from China. While the firm did respond, providing its HACCP plan with a hazard analysis for various produce from USA and Mexico, the plan did not document a hazard analysis for the ginger from China.
- Another importer’s 483 response stated that it had hired an outside consultant to develop its FSVP, estimating it would be completed within 6 to 8 months. However no supporting documentation was provided to enable FDA to evaluate the adequacy of the response, and, the warning letter stated, that response was “similar to statements you made in your responses to previous inspections.”
- A third importer, that received a 483 on February 22, 2024, received a warning letter from FDA two months later (April 22) because the firm had not responded at all to the 483.
In each case, the importer was given only 15 working days to respond, addressing the corrections being made for the violations, including documentation.
However, that 15-day period does not necessarily extend to the allowance for the firm to continue to import. Rather, when a warning letter is issued, the importer can be subject to import refusals or placed on import alert, resulting in the automatic Detention Without Physical Examination (DWPE) of all future shipments until the import alert is resolved. Additionally, at this point, getting off an import alert requires more than the standard submission of a petition evidencing root cause analysis, corrective action, verification, and five consecutive shipments released as compliant. The firm’s petition must also demonstrate compliance through proven corrective action. If accepted, the importer will be removed from DWPE, but the process can take months.
While FDA originally implemented its now-standard “educate while we regulate” approach to the FSVP Rule, the rule has been in effect for all businesses – large, small, very small, and other – since at least 2020, so that enforcement discretion has long since passed. So, firms of all sizes and locations are subject to FSVP inspections – and citations.
One provision of the rule is that a qualified individual (QI) develop and maintain the FSVP and perform certain risk-based activities to verify that a food to be imported to the U.S. was produced in a manner that meets U.S. food safety standards. Some of the activities required to be performed or overseen by the QI are:
- Perform a hazard analysis that includes identifying known or reasonably foreseeable hazards associated with each type of food and determining if they require a control.
- Evaluate risks posed by the food and the performance of the foreign supplier.
- Conduct appropriate supplier verification activities to provide assurance that the hazards requiring a control in the imported food have been significantly minimized or prevented.
- Take corrective actions where needed and investigate the adequacy of the FSVP.
- Reevaluate the food and foreign supplier every three years, or sooner if there is new information about hazards in either.
At 126 pages in the Federal Register, the rule is quite complex; and the responsibilities of the QI can be challenging, as an FSVP must be developed and executed for each imported food from each supplier. But, as the number of 483s and seriousness of warning letters show, it is critical that the rule be thoroughly understood and implemented to ensure your imports make it across the border.
TAG can help. To assist in your FSVP development, TAG is offering a virtual FSVP QI training on July 9 – 10, 2024. Following the standardized FSPCA curriculum recognized by FDA, the course provides participants with the education and training needed to become a QI and develop and implement an FSVP to keep you safe from 483s and warning letters. Contact us today to register; to request assistance in the development or review of your FSVP – or to act as your QI!
