In recent months, the U.S. Food and Drug Administration (FDA) has issued a dozen warning letters over Foreign Supplier Verification Program (FSVP) violations. These food industry FSVP violations underscore the increasing eye on the risks to public safety within the global supply chain.

Part of the Food Safety Modernization Act (FSMA), the FSVP requires manufacturers to develop, maintain, and follow an FSVP for all foods imported from foreign suppliers. The FSVP includes elements such as:

  • Identifying hazards associated with imported foods
  • Conducting a hazard analysis to assess supplier performance evaluate the risk of individual foods
  • Performing appropriate supplier verification activities, as well as corrective actions

In this article, we review some of the most common FSVP violations highlighted in FDA warning letters. We also discuss how an automated quality management system (QMS) can help minimize the risk of violations, protect consumers, and reduces compliance issues.

 The Number One FSVP Violation

Strikingly, the common thread that connects the majority of warning letters related to FSVP compliance is not having an FSVP at all. In fact, several manufacturers were cited for not having an FSVP for any of the foods they import.

Additionally, some companies justified the lack of an FSVP because they imported products from a country with a food safety system equivalent to the United States. In these cases with an officially recognized food safety system, says the FDA, the requirements are as follows:

  • U.S. importers still need an FSVP for imported foods, following the modified requirements in 21 CFR 1.513
  • Before importing the food, companies must document that the foreign supplier is in good standing with their country’s food safety authority

In other situations, manufacturers thought they didn’t need an FSVP if they are “very small importers.” If you are one, however, you must still:

  • Follow modified FSVP requirements in 21 CFR 1.512
  • Document that you meet the definition of very small importer
  • Obtain written assurance that the suppliers’ processes provide the same level of public health protection as the U.S. food safety system, both before importing the food and at least every two years thereafter

Why is this lack of compliance so common? Consider a few factors.

First, it’s becoming clear that many of these importers lack the internal knowledge required to maintain FDA compliance. This problem highlights the need for dedicated compliance staff.

Second, there is no FSVP process model or form from the FDA that importers can follow. That means they are left to create it from scratch, and some apparently opted to ignore it altogether.

Documents that are required to prepare for an FSVP inspection are:

  • Food safety certification
  • Product specification
  • Food safety plan
  • Allergen compliance
  • Additive compliance
  • Laboratory analysis and contact surfaces
  • FDA-compliant labels

Reviewing and Assessing a Foreign Supplier’s Hazard Analysis

Several warning letters note a failure to document a review and assessment of a foreign supplier’s hazard analysis. FSMA requires a hazard analysis for each imported food to determine whether any hazards require a control.

This hazard analysis may be conducted by a qualified individual with another entity. FSMA requires, however, that manufacturers document the following:

  • That the company has reviewed and assessed the hazard analysis
  • That the initial hazard analysis was performed by a qualified individual

Approval Process for Foreign Suppliers

How manufacturers approve foreign suppliers is another big issue that appears frequently in FDA warning letters. The FDA points out that approval must be based on an evaluation of both the foreign supplier’s performance as well as the risk posed by the imported food.

Again, where another entity performs this evaluation, the manufacturer must document their review and assessment of the evaluation. They must also document that a qualified individual conducted the evaluation.

Other issues around approving foreign suppliers include:

  • Not establishing and following written procedures to ensure that Foods are only imported from suppliers approved based on evaluation of food risk and supplier performance
  • Not establishing and following procedures for conducting foreign supplier verification activities
  • Not determining and documenting verification activities and frequency before importing foods

Not Providing a Timely Response to a Form 483 Observation

Another common issue seen in recent FDA warning letters around FSVP compliance is the lack of timely response to a previously issued FDA Form 483 observation. In other words, manufacturers were initially issued a 483 observation, but because they failed to provide an adequate response in the required time, FDA issued a warning letter.

It’s understandable given that the FDA requires a reply to a Form 483 observation letter within just 15 days. However, the fact remains that many warning letters could be avoided simply by addressing concerns in the initial observation in a timely manner.

FSVP Compliance: The QMS Advantage

Working with a tapestry of spreadsheets and manual processes will no longer suffice in the new age of food safety. The best measure to avoid FDA warning letters and FSVP compliance issues is an enterprise quality management software solution.

First and foremost, automation improves the process of developing, maintaining, and following written procedures, including retaining auditable documentation of:

  • The FSVP itself
  • The hazard analysis and the qualified individual who performed it
  • Your approved supplier list (ASL), communication with suppliers, and supplier performance data
  • Verification procedures and compliance records
  • Employee training
  • Changes to procedure documents
  • Use of forms to comply with labeling requirements

A QMS also helps ensure a rapid response when communicating with regulators. It’s a critical concern, given that companies have only 15 days to respond to an FDA 483 observation. The QMS streamlines the process by giving you a single system that acts as a trusted source of quality data, so you can:

  • Document supplier-related quality problems and link them to corrective actions
  • Track supplier corrective action request (SCAR) and action items
  • Assess risk of individual suppliers
  • Use supplier scorecards to track supplier performance
  • Qualify and onboard new suppliers, as well as track and remove non-qualified suppliers
  • Create scheduled reports based on detection rules for all suppliers, including import performance by food or product
  • Automate actions based on supplier performance


Recent FDA warning letters highlight a number of common issues around FSVP compliance. Documentation is one of the biggest issues, specifically regarding hazard analysis and approval of foreign suppliers. Training is also a systemic problem, while lack of a formal FSVP template from the FDA is also leading to many repeat observations.

An automated QMS helps address the root cause of observations, starting with document control and training to create the FSVP. Just as important, it helps sustain the program with solutions such as incident and corrective action tracking, supplier agreements, scorecards, and more.

View our infographic on the 9 Benefits of A Supplier Scorecard

About the Author

Sal Lucido is Co-Founder and Executive Vice President AssurX. Sal is an unequivocal product evangelist and an expert in the area of quality process automation. He holds a broad array of responsibilities, ranging from overseeing strategic plans and operational improvements to managing tactical alliances.

Related Reading:

Supplier Quality Management: A New QMS-Based Approach

FDA Warning Letters Highlight Food Safety Compliance Issues