FDA Foreign Verification Programs

Background - Striving for a Safer Food System

Before the FDA established FSVP as a component of FSMA, companies only needed to have an importer of record. The FDA could inspect a firm’s product at port of entry for pathogens, chemicals, or other documentation to ensure the safety of the product. This was the only way to verify to the safety of the global supply chain of a firm. This process was not as comprehensive as the FSVP that is in place now. On November 16, 2015, FDA published the FSMA final rule on Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals and the first compliance dates began May 30, 2017. The final rule requires that importers perform certain risk-based activities to verify that food imported into the United States has been produced in a manner that meets applicable U.S. safety standards. Importers must also verify that the food is not adulterated or that the human food is not misbranded (concerning food allergen labeling). Only the U.S. based importer or U.S. agency, or representative of the foreign owner are responsible for developing and maintaining a FSVP. With over 50% of the U.S. fresh produce being imported, FSVP is a critical program to ensure that food entering is wholesome and safe for consumption by Americans.

This resource summarizes insight gained through interviews with IFPA Food Safety Council Members who have undergone one or more FSVP inspections. Additionally, publicly available data from the FDA website (as of July 2023) has been compiled to identify the most common findings in FSVP inspection.

Ultimately, this information is presented as a case study to identify best practices and provide recommendations on how IFPA member companies can effectively pass FSVP inspections.

Jump to frequently asked questions

What the FDA has Found So Far

These are the top citations found during FSVP-related inspections from 2016 – 2023. Inspectional data was collected from the FDA Compliance Dashboards. Note that FDA reports common inspection findings of all food companies but produce companies' perspectives will be explored.

1. Develop FSVP
   “You did not develop an FSVP.”
   • Developing a FSVP is the first step in ensuring your firm complies with regulations.
2. Supplier verification - establish written procedures

   “You did not establish adequate written procedures for ensuring that appropriate foreign supplier verification activities are conducted with respect to a food you import.”

   • Having a FSVP in place is important, but it must be maintained and followed as well. This citation essentially states a firm does not have a satisfactory procedure for verifying their suppliers.

3. Verification activity assurance
   “You did not determine and document which verification activity or activities were needed to provide adequate assurances that a food you obtain from a foreign supplier is produced in compliance with processes and procedures that provide the required level of public health protection.”
   • A firm has not verified that their supplier is producing food in a way that is safe. For example, this could be not having a sufficient hazard analysis for each supplier a firm imports from that identifies and has a plan to control all reasonably foreseeable hazards.
4. Record – translate to English
   “You did not provide an English translation of an FSVP record that you maintained in a language other than English.”
   • With companies working with foreign suppliers, it is reasonable that some records are not kept in English. However, the FDA requests that companies provide English translation of all required FSVP documentation for inspections. Companies should try to obtain these translations, if necessary, upon inspection notice.

Recommendations based on IFPA Member Experiences

1. Read the law carefully and understand the basic requirements you need to follow. (food safety audit, checklist, hazard analysis, certificates).
   a. Utilize FSVP guidance documents and FDA resources. Completing additional training programs (e.g. developed by FSPCA) may also be beneficial.
2. Verify all contact information is correct with your firm’s customs broker.
3. Have your FSVP documentation organized before business is started with a supplier.
   •  Review your paperwork and keep documentation to know who is responsible for certain FSVP activities.
4. Depending on your firm, it may be beneficial to require your suppliers to undergo third-party GAP certification by a standard that is aligned with FSMA requirements. Alternatively, some standards offer FSMA add-ons.
5. Establish SOPs that comply with FSVP guidelines. SOPs should be accessible to workers and easy for them to understand.
6. Keep it simple. Provide required paperwork to FDA but don’t overshare information (can lead to confusion and more digging).
7. Ask for clarification if FDA instructions are vague.
8. Be patient and be prepared to walk the inspector though your supply chain process.

Remember that the FDA is not trying to shut you down. Go into the inspection with a good attitude and be willing to work with the inspector.

IFPA Members’ Experiences During FSVP Inspections

1. Commodities: Berries
   
   Supply Chain Area: Grower/Shipper/Distributor
   
   No. of FSVP Inspections: 1
   
   Latest Inspection Date: Summer 2022
   
   Communication with FDA throughout inspection: Good. When initially contacted by FDA, the wrong contact person was listed for the firm. This was ultimately corrected with their customs broker. Once mitigated, the member received an initial alert about inspection via email and inspector followed up with firm in timely manner – 2 weeks after documents submitted for review.
   
   General Experience: The inspection was done remotely. This member sent the FDA the minimum required documentation for their audit including food safety audit information, FSVP checklist, hazard analyses, and appropriate certificates. Within two weeks, the firm was notified by the FDA that they passed inspection and no corrective action was needed. This member felt prepared for their FSVP inspection and underwent FSVP training through FSPCA, hosted by IFPA (formerly United Fresh Produce Association).
   
   Approach to Supplier Verification: The member individually reviews the hazard analysis from farms to verify it complies with FSVP.
2. Commodities: Avocados and Mangoes
   
   Supply Chain Area: Grower/Distributor
   
   Communication with FDA throughout inspection: This member felt they had good communication with the FDA during their inspection process and has started building a connection with their inspector.
   No. of FSVP Inspections: 3
   
   Latest Inspection Date: June 2022
   
   General Experience: This member has had a generally good experience for there FSVP inspections. With two of the inspections, the member experienced consistency from having the same inspector. After the second inspection, this firm had a better understanding of what to expect. In the third inspection, the member had a different inspector and had a different experience. This member expressed some concerns about the subjectivity of inspections and consistency between inspectors, the industry’s understanding of FSVP, and the inspectors’ knowledge of the produce industry. This member stated that they have had to teach inspectors more about their specific process due to them not being well versed in all types of produce commodities.
   
   In the third inspection, the inspector requested documentation from the farm level that the firm was unable to provide. FSVP requires companies to provide verification all the way down to the farm level (i.e., the foreign supplier), but many farms for this firm do not handle the hazard analyses and food safety plans. Instead, this is managed by packhouses. To mitigate this issue, the member recommended its farms to get a FSMA add-on when they have their current GAP audit. In regard to the designation of importer for FSVP, this firm has become more aware of being put down for a supplier as having dealt with being incorrectly listed before. This member completed FSVP training through FSPCA.
   
   Approach to Supplier Verification: This firm does an initial audit of packhouses to check if their hazard analysis meets FSVP standards. If it does, the firm will accept and use that for documentation. If not, the firm will work with the packhouse to improve their plan. Chemical hazards are the main dictator for this company on where their product will go and then they follow up with a biological hazard check. Chemical hazards concerns for this company are primarily pesticide residues.
3. Commodities: Berries, Peas, French Beans, Brussel Sprouts
   
   Supply Chain Area: Grower/Shipper/Packer
   
   No. of FSVP inspections: 2
   
   Latest Inspection Date: February 2023
   
   Communication with FDA throughout inspection: The member had good communication with the inspector, however, the firm did need to have their contact information updated by their customs broker.
   
   General Experience: In the first inspection, the inspector asked many questions and had a structured way of conducting the audit. The second inspection was done by a different inspector and was more informal. This firm now has a plan in place and utilizes excel to organize its supplier information to make it easier to send. The member noted the inspector for their second inspection was also conducting another inspection that was troublesome, which caused the inspector to be delayed in communication and not ask as many questions. This member also expressed concern with potential inconsistency between different inspectors.
   
   This firm had one issue with being designated as the importer for a supplier that they did not do business with. This member has done standardized FSVP training through FSPCA, which they feel has allowed them to better understand the regulation. However, they also noted they believe the way the regulation is written can lead to confusion as produce companies try to adhere.
   
   Approach to Supplier Verification: This firm creates a hazard analysis for each product country to identify general hazards associated with that country/commodity. The firm also reviews each supplier’s hazard analysis for specific hazards each supplier needs to control. For this firm, pesticide residue issues are a common concern.
4. Commodities: Citrus fruit, Apples
   
   Supply Chain Area: Wholesaler/Distributor
   
   No. of FSVP inspections: 1
   
   Latest Inspection Date: March 2023
   
   General Experience: This firm experienced some challenges during the inspection. The associates who are responsible for FSVP documentation were undergoing FSVP training during the time of inspection. The FDA inspector pulled 3 of their suppliers at random and requested documentation which the firm was unable to provide at the time. The firm received a two-week extension but was still unable to provide documentation. This firm received an additional extension with the issuance of an FDA 483 Form. Additionally, the FDA inspector sent a letter to the firm’s CEO about inspection which detailed the events of inspection, including documents the firm provided and all corrective actions needed to be taken. The firm is still in the process of correcting their FSVP and has been working with their suppliers consistently on these issues. They have encountered problems with translation of documents from their supplier as well as receiving documentation. The inspection was done entirely remote. The firm hasn’t had any problems with being designated as importer for a supplier they don’t do business with. This member has completed FSVP training developed by FSCPA.
   
5. Commodities: Berries and Tomatoes
   
   Supply Chain Area: Grower/Shipper
   
   No. of FSVP inspections: 1
   
   Inspection date: Spring 2023
   
   Communication with FDA throughout inspection: Generally good throughout the process. This member stated that once they were contacted about an upcoming inspection, they asked what information could be sent ahead of time. They believe this was helpful in making their audit run smoother.
   
   General Experience: This member had a good experience with their inspection, originally expecting it to be more difficult. They explained how their firm already had a program in place to supervise the implementation of food safety programs for their suppliers. The firm had to adjust their program slightly to align with FSVP regulations, but it wasn’t too difficult given the firm already had most of the necessary documentation. This member emphasized a crucial component of their success was creating procedures that team members could understand. This member completed standardized FSVP training through FSPCA, hosted by IFPA (formerly United Fresh Produce Association).
   
   Approach to Supplier Verification: This firm requires their growers to have a food safety person/team to handle the completion appropriate documentation (e.g., hazard analysis). The most troublesome hazard area for their commodities is the treatment/filtration of the water used for growing.
   

How Does This Stack up?

Compared to the FDA’s “What to Expect During a Foreign Supplier Verification Programs Inspection” document, members’ experiences have been fairly consistent. Generally, members have had a good experience with inspections considering their interactions and communication with the FDA. This open communication is a crucial component of success during inspections as many times it may be necessary for a firm to further explain their process to an inspector beyond submitting required paperwork. Many members also expressed concern for consistency between inspection due the subjective nature of inspectors. Knowing the requirements of FSVP regulations, having all documentation organized, understanding your firm’s process, and having a helpful attitude toward inspectors can help mitigate these issues. As an additional question, members were asked if their firm has considered participating in the Voluntary Qualified Importer Program. VQIP is a voluntary fee-based program that provides expedited review and import entry of human and animal foods into the United States for participating importers. The consensus among interviewed members is that the program is not viable for their firm, or their firm already participates in a program that is perceived to grant them similar benefits (e.g., CTPAT).

Additional Resources

• IFPA FSVP Q&A – Answers commonly asked questions about FSVP.
• FDA FSVP Main Page – Landing page for all FSVP-related resources.
• FDA Key Requirements Document – Offers an at-a-glance overview of all FSVP requirements.
• FSMA Technical Assistance Network (TAN) – Additional questions about how the rule may apply to you can also be submitted through TAN. Companies are encouraged to be very specific about their circumstances when they submit questions to help the FDA experts give them the best advice on how the rule applies to them.

The following is offered for informational purposes and does not constitute legal advice. Official interpretations of FDA rules can be obtained by submitting an inquiry to FDA’s Technical Assistance Network (TAN). For scientific and technical questions (e.g., related to hazards, test methods, etc.), reach out to the Technical Assistance Network of the Food Safety Preventive Controls Alliance. You can also visit FDA’s FSMA website for official information, and sign up to receive alerts directly from FDA.

If my company is listed as an FSVP importer and believe that it is in error, what should we do to let FDA know?
FDA publishes the list of FDA importers quarterly based on customs entry filings. If you believe you have been listed in error, FDA suggests you file a Freedom of Information Act request. Based on our discussions with FDA, we developed a document on how to file a FOIA request that is likely to provide useful information to you (below).

I got a notice from FDA that I need to have a DUNS number, and that UNK will no longer be accepted. What should I do?
The final rule requires that the Customs Entry forms indicate the FSVP importer, including their DUNS number. FDA allowed a 5-year transition period for firms to obtain a DUNS number, and allowed the use of ‘UNK’ in the interim. As of July 24, 2022, UNK is no longer being accepted. DUNS numbers are specific to location and you may get a rejection or note from FDA if they see the same DUNS number associated with more than one location. You can request a new DUNS number from Dun & Bradstreet (D&B) through the D&B’s Import Safety Lookup Portal https://www.importregistration.dnb.com. You may also use the Portal to look-up a DUNS number or request an update to a current DUNS number.

If I import produce that isn’t subject to the produce safety rule (e.g. potato, asparagus, and other produce that is rarely consumed raw– see the list here) am I exempt since my foreign supplier (grower) is not subject to the Produce Safety Rule?
No. Just because your foreign supplier is exempt from the Produce Safety Rule, it doesn’t mean that you are exempt from FSVP. You still need to conduct a hazard analysis of the food (including chemical hazards such as pesticides, which are not addressed by the PSR), at a minimum, and fulfil the other FSVP requirements based on the hazard analysis.

My supplier is a distributor, aggregator, etc. Who and what am I supposed to verify?
“Foreign supplier” is defined as “the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature” (see p 74341 of the rule). A distributor or aggregator does not meet this definition. As defined in the rule, the foreign supplier is the one growing or producing the food, and may be more than 1 step back in the supply chain. The rule requires you to verify that that entity is controlling the hazards identified in the hazard analysis as needing control.

Who is the foreign supplier of a produce RAC, the farm or the packinghouse?
“Foreign supplier” is defined as “the establishment that manufactures/processes the food, raises the animal, or grows the food that is exported to the United States without further manufacturing/processing by another establishment, except for further manufacturing/processing that consists solely of the addition of labeling or any similar activity of a de minimis nature” (see p 74341 of the rule). FDA has indicated that since a packinghouse does not do “manufacturing/processing”, the foreign supplier of a RAC would generally be the farm.

If I’m not the importer of record (which is a requirement of Customs and Border Control; not identical to FSVP importer), but I use imported products/ ingredients, do I need to comply with FSVP?
Maybe. The FSVP importer may be different from the importer of record. It depends on whether or not you meet the definition of FSVP importer, which is “U.S. owner or consignee of an article of food that is being offered for import into the United States. If there is no U.S. owner or consignee of an article of food at the time of U.S. entry, the importer is the U.S. agent or representative of the foreign owner or consignee at the time of entry, as confirmed in a signed statement of consent to serve as the importer under this subpart.” There are instances where the importer of record may not meet this definition (e.g., by not being US based), however an FSVP importer still needs to be identified.

Should I sign a letter from my customer asking me to take responsibility as the FSVP importer?
This depends on whether or not you meet the definition of an FSVP importer. If you do not meet this definition, you cannot be the FSVP importer.

I meet the definition of FSVP importer, but so does my customer (because they have agreed in writing to purchase the imported food from me). They are asking me to sign a statement saying I will bear the responsibilities of the FSVP importer. Is that allowed?
It’s true that in some situations, more than one entity may meet the definition of the FSVP importer. In that case, the supply chain needs to determine who, singularly, will be listed as the FSVP importer for that line of food on the Customs entry form, and be responsible for compliance (hazard analysis, supplier evaluation, approval, and verification activities). Signing a statement at your customer’s request is a business decision. Note that FDA requires records be retained for 2 years. If your supplier asks for a longer retention time, agreeing to that is a business decision; FDA will have access to records for as long as you keep them.

My foreign supplier (or broker, or customer) already conducted a hazard analysis for the product. Can I use that?
Yes, but you need to have it reviewed by a qualified individual who is able to ascertain if the original analysis is adequate. Also, you need to maintain documentation showing which hazards you are expecting the supplier to control (e.g., the hazard analysis, or comparable document).

The rule says that I don’t need to conduct a hazard analysis when I am importing produce covered by the Produce Safety Rule. Does this mean I don’t need to do anything to comply?
No. First, you do need to conduct a hazard analysis for any chemical or physical hazards (e.g., if the food is imported from a region where pesticides are not properly applied, or where there is high pollution, you may identify these hazards as needing controls). Second, the reason that you don’t need to evaluate microbiological hazards is because FDA assumes they are there and need to be controlled (through the implementation of the Produce Safety Rule). Therefore, you will always need to conduct verification of a farm growing covered produce (or ensure someone else in the supply chain is verifying the farm).

What does enforcement look like?
FDA is enforcing this rule. Importers are being contacted, often via email, to provide records demonstrating FSVP compliance. There are already several examples of FDA issuing warning letters to importers due to FSVP violations. The most common citation is not having an FSVP! A

FOIA REQUEST

Note to Industry: Addressing Erroneous Inclusion on FDA’s FSVP Importer List

Background

On a roughly quarterly basis, FDA posts the names of entities that have been identified on Customs Entry paperwork as FSVP importers. This list can be downloaded at the bottom of this page: https://www.fda.gov/food/importing-food-products-united-states/foreign-suppliers-verification-programs-list-participants. As of this writing, the list is sorted by state, and then by firm legal name, and the file contains the timeframe for which information is provided.

From time to time, companies have been surprised to see their names listed as FSVP importers. This document lays out the process to request details from FDA in order to understand how a company name/location wound up on the list.

If you don’t think you’re an FSVP importer:

At the web link above, FDA states “If you would like more information regarding entries for which you were declared as the FSVP importer, you can submit a Freedom of Information Act Request to request the publicly releasable data points for those entries for a related timeframe.” This document provides additional details on how to do this, and the information that should be provided by the inquiring firm in order to expedite a response from FDA.

• The company who feels they have been listed in error must file a Freedom of Information Act request. If the firm would like a 3rd party (e.g., an attorney) to make the request, the firm listed as the FSVP importer must grant permission to the 3rd party (e.g., on company letterhead) and this must accompany the request by the 3rd party.
• The FOIA request should include the dates/ timeframe of interest (e.g., if you’re listed in a report that covers March – May 2020, this would be the timeframe of interest). Bear in mind that implementation of the FSVP rule began May 30 2017; FSVP for importers of fresh produce covered by the Produce Safety rule began July 26, 2018. The broader the timeframe of the FOIA request, the longer it may take FDA to respond.
• The spelling of the firm name in the FOIA request should exactly match the spelling on the FDA list (even if there are typos). It’s recommended to also include the correct spelling, as well as any alternate spellings, subsidiaries, DBAs etc.
• The FOIA request should also include the DUNS number, and/or location of the alleged FSVP importer. Otherwise, a company with multiple locations may receive data for all locations (and again, the more extensive the request, the more time it will take for the agency to respond).

This information is provided as a service to the industry. It is not legal advice and is subject to change. Contact FDA or an attorney with specific questions.

Expected timeframe for response

FDA has dedicated staff and established processes to handle these FOIA requests. You should expect a response in about one month, depending on the scope of the request.

What to expect from the FOIA response

The inquirer will receive 23 data points associated with the entry(ies) in which the firm was listed as the FSVP importer. This includes the filer, the port of entry, and other information that the firm can use to follow up with those parties to address the improper naming of the FSVP importer.

NOTE

If you determine that you were improperly listed as the FSVP importer, be aware that the published list will not change, because the list reflects the company reported as the FSVP importer at the time of entry. However, your investigation into the error will be helpful so that in the future, the FSVP importer will be entered properly. You should proactively contact the filer and alert them that the declared FSVP importer is not the true FSVP importer and that they should identify the correct FSVP importer moving forward. It’s recommended to keep documentation of your inquiry, and any follow up with the filer, in case you are notified by FDA of an FSVP inspection related to this entry.