Fabiola Negron

Director of Food Safety

FDA Issuing Warning Letters for Preventive Controls and FSVP Violations

Sep 10, 2019

Under the Food Safety Modernization Act (FSMA), most food facilities operating in or exporting to the U.S. are required to have a Food Safety Plan following the Hazard Analysis and Risk Based Preventive Controls (HARPC) method. The Act also requires U.S. importers to have a Foreign Supplier Verification Program (FSVP) for all imported food products or ingredients. Most of the compliance deadlines for these rules have passed and the U.S. Food and Drug Administration (FDA) has been increasing enforcement of these rules during facility inspections leading to FSVP violations. It should be expected that FDA will continue to ramp up enforcement efforts, meaning it’s prudent to have your Food Safety Plan and/or FSVP in place to avoid a compliance issue with FDA. 

Once the initial deadlines had passed, FDA focused on educating facilities to make them aware of the new rules and understand what was expected of them. In 2018, FDA more actively cited violations of FSMA regulations during facility inspections.  In fact, failure to develop an FSVP was the most frequently cited violation that year.  FDA has continued to enforce these rules in 2019, issuing several warning letters addressing companies for FSMA violations.

Having a Compliant Food Safety Plan and Executing It

For some facilities, not having a Food Safety Plan is still an issue. In this warning letter, FDA notes that the company has been required to develop a Food Safety Plan since September 18, 2017. With a reasonable amount of time having passed since the deadline, FDA will likely check to see if your facility has a Food Safety Plan in place. A complete Food Safety Plan identifies all potential biological, chemical (including radiological), and physical hazards to a food’s production and then establishes controls to contain or eliminate these hazards.

It is necessary to be thorough when creating your Food Safety Plan, as it is a common problem to leave out a component of the plan or to not identify all of the potential hazards in a facility and establish controls for those hazards. In this letter, the facility failed to identify potential environmental hazards or establish allergen controls, both required components of a complete Food Safety Plan. Facilities are also required to maintain written records on monitoring, corrective actions, and verification of the controls. Failure to adhere to any of these or other requirements of a Food Safety Plan can result in a citation or warning letter.

Once your facility’s Food Safety Plan is written and in place, you must continually execute it and keep it up to date. You should implement the plan as a part of your facility’s standard operating procedure, incorporating it into your facility’s every day activities. You should reevaluate the plan at least once every three years or if any issues arise. All employees should be trained on what is required and what their role and responsibility is towards executing the plan. FDA may check to make sure your employees are executing your Food Safety Plan even if it is written. Failure to actually execute the plan can result in a warning letter or other regulatory action.

FSVP Violations

U.S. importers are required to verify and approve that their suppliers products meet the food safety standards of the United States. Importers must establish and follow written procedures to import products only from approved suppliers. Importers are responsible for confirming that the products they import follow applicable FDA regulations, such as Preventive Controls rules or Current Good Manufacturing Practices. These need to be developed for every individual product that is imported. Suppliers must be re-evaluated at least once every 3 years.

FDA recently issued their first warning letter for failure to comply with the FSVP rule. According to FDA, “Moving forward, the FDA will take more steps to ensure compliance with FSVP, including reinspecting importers that had deficiencies in previous inspections and by acting immediately when FSVP deficiencies are found that pose an imminent public health risk”. If a facility receives a warning letter for FSVP violations, they are required to respond to the letter within 15 days with corrections to the violations. FDA may subject the importer to Import Alert #99-41, Detention without Physical Examination of Human and Animal Foods Imported from Foreign Suppliers by Importers Who Are Not in Compliance with the Requirements of the FSVP Regulation. FDA is taking FSVP enforcement seriously, and importers should ensure they have compliant FSVPs in place immediately.

Registrar Corp is the world’s largest regulatory consulting provider, assisting over 30,000 companies each year across. We can assist you in ensuring your Food Safety Plan is FDA compliant so your inspections will go smoothly. We can also help importers develop a FSVP.  For more information, contact us at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at


Fabiola Negron

Director of Food Safety

Widely respected in the Food Safety industry, Fabiola provides insightful education to food and beverage companies worldwide on U.S. FDA regulations resulting from the passage of the Food Safety Modernization Act (FSMA) in 2011. Her expertise in creating and reviewing Food Safety plans, helping U.S. importers comply with Foreign Supplier Verification Program (FSVP) regulations, and leading our Food Safety team have helped hundreds of companies comply with FDA food and beverage requirements.

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