FIC Blog - FSVP Compliance

Top 5 FSVP Violations Found During FDA Inspections

Written by Bita Saidi 
March 4, 2026

Understanding the Role of FSVP in Protecting Imported Food

The globalization of the food supply has made it possible for consumers in the United States to access foods from virtually every corner of the world. While this diversity benefits consumers and businesses, it also introduces new food safety challenges. To address these risks, the FDA established the Foreign Supplier Verification Program (FSVP) rule as part of the Food Safety Modernization Act (FSMA).

The FSVP rule places a clear responsibility on FSVP importers to ensure that the foods they bring into the US meet the same food safety standards required of foods produced in the US. At a very high level, they must verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as applicable FDA regulations. 

What FDA Inspection Data Reveals About FSVP Compliance

To ensure that importers are meeting their responsibilities under the FSVP rule, the FDA conducts inspections and reviews of importer compliance. During these inspections, FDA investigators evaluate whether importers have properly developed and implemented their FSVP programs. When deficiencies are identified, FDA documents them as citations under the FSVP rule.

To better understand common violations, the FIC chart below shows 10,845 FSVP inspection citations extracted from the FDA Data Dashboard “Inspection Details” dataset.

Figure 1. Most Common FSVP violations identified during FDA inspections, based on analysis of 10,845 inspection citations from 6,076 FDA inspections conducted between June 30, 2017 and February 12, 2026.

While violations occur across many different FSVP requirements, one issue stands out clearly from the rest; the requirement to develop and maintain an FSVP. 

Closer Look at the Top 5 Most Common FSVP Violations

1) Failure to Develop an FSVP (21 CFR 1.502(a))

Failing to develop an FSVP alone accounts for about 41% of all citations. 

During inspections, FDA cites this requirement when FSVP importers do not have a formal FSVP at all or have incomplete documentation that does not clearly demonstrate compliance. The regulation requires the importer to conduct its own risk-based evaluation and verification process, tailored to the specific food and supplier, which goes far beyond relying solely on supplier certifications.

Unless exempt or subject to modified requirements, FSVP importers must develop, document, and maintain an FSVP for each imported food and foreign supplier. Without an FSVP, the importer cannot demonstrate that hazards have been evaluated or that suppliers are being verified appropriately, let alone ensure the safety of the imported food.

To learn how to develop an FSVP and understand the full technical requirements of the regulation, you can start the online self-paced FSPCA FSVP training anytime.

2) Failure to Evaluate Foreign Supplier Performance and Risk (21 CFR 1.505(a)(2))

The second most common violation involves the requirement for importers to evaluate the performance of the foreign supplier and the risk posed by the food before approval and import.

FDA cites this issue when importers approve suppliers without conducting a structured evaluation or when documentation supporting the evaluation is incomplete or missing. Importers can strengthen compliance by implementing a clear supplier approval framework that properly evaluates food safety hazards and supplier performance history. 

3) Failure to Establish Approved Supplier Procedures (21 CFR 1.506(a)(1))

Another frequently cited requirement involves establishing procedures to ensure that imported foods come only from approved foreign suppliers (with some exceptions).

FDA cites this provision when companies lack a defined process for receiving product from approved suppliers (for example using a supplier approval procedure and checklist).

4) Failure to Establish Written Supplier Verification Procedures (21 CFR 1.506(b))

The fourth most commonly violated FSVP requirement is establishing and following written procedures for conducting foreign supplier verification activities.

FDA cites this requirement when importers conduct verification activities but fail to document clearly defined procedures governing those activities. Establishing written procedures is required to ensure that verification activities such as audits, sampling and testing, or record reviews are performed systematically and that responsibilities and frequencies are clearly defined.

5) Failure to Determine Appropriate Supplier Verification Activities (21 CFR 1.506(d)(1)(i))

Rounding out the top five FSVP violations is the requirement for importers to determine appropriate supplier verification activities based on the risks associated with the food and the performance of the foreign supplier.

A violation may be cited when an importer applies the same verification activity to multiple suppliers without evaluating the specific risks associated with each supplier individually.

Strengthening FSVP Compliance Through FSPCA Training

For many organizations, compliance challenges stem from limited familiarity with the detailed requirements of the regulation. Understanding how to conduct hazard analyses, evaluate supplier risk, select appropriate verification activities and meet all of the other FSVP requirements, requires specialized knowledge.

Training can play an important role in helping importers build effective FSVP programs. That's why FIC offers the FSPCA Foreign Supplier Verification Program (FSVP) training course in two formats: self-paced online FSVP training and live virtual FSVP training, allowing you to choose the FSVP training format that best fits your schedule and learning preferences. 

FIC's FSVP Course follows the standardized curriculum developed by the Food Safety Preventive Controls Alliance (FSPCA) and recognized by the FDA. Participants can explore the requirements of the regulation in detail, review practical examples, and learn how to properly document FSVP programs in a way that meets FDA expectations.

Overall, understanding the FSVP requirements and how they apply in practice can help importers strengthen compliance and reduce the likelihood of FSVP violations during FDA inspections.