No matter the stage of food importing of your business, we have practical solutions. Food safety is an essential expense to your food business, but it doesn’t have to put you out of business. Many consultants and firms have programs and processes that drastically cut into a food company's bottom line making it impossible to make a profit. Our consultants are scientists that understand business! We care about the needs of the consumer and the business owner.
Our consultants have firsthand experience dealing with Federal regulators and have proven solutions that have been accepted by the FDA. We have experience interacting with compliance officers, investigators, auditors, and regulators in many sectors of the government. We have successfully assisted clients with inspections, enforcements, depositions, and more.
Call us today to discuss your food importing needs. We will evaluate your current situation and determine your needs for compliance, develop a tailored solution that is practical for your business, and support your business during FDA FSVP inspections. If you have received an enforcement such as Form 483 or a Warning Letter, we will assist you in prompt resolution with the government.
Bottom-line - you don't want to be on the wrong side of the Feds!
What IS your current situation?
Planning on importing food into the United States?
If your food business is importing food products into the United States it is important to be proactive in your Foreign Supplier Verification Program (FSVP) activities to avoid costly and embarrassing regulatory enforcement actions. If your food business is planning to import food products, call us today to determine your needs for compliance. We provide FSVP for food importers.
We will develop an FDA compliant FSVP to ensure compliance and seamless entry into the US. Developing a compliant program prior to importing food ensures compliance during future inspections.
Received a Regulatory Enforcement Action - Form 483, Warning Letter, Citations?
The FDA conducts routine facility inspections of food facilities registered with the FDA. Your facility is selected at random. The FDA also conducts inspections in response to complaints, recall investigations or findings during inspections of food facilities your company does business with.
If a food facility is importing food into the US without a compliant FSVP there are several possible enforcements actions:
If you have received an enforcement action from the FDA it is crucial your company responds within the assigned deadline to avoid escalations and additional enforcement actions. If your company has received an action, call us today to determine the solution for prompt resolution with the government.
Does a very small importer have to comply with FSVP?
Yes. While the requirements for a very small importer are condensed, there are a number of regulations in the Code of Federal Regulations (CFR) a very small importer must comply with. If you are a very small importer planning to import food OR if you are already importing food and do not have a compliant FSVP, call us today to discuss solutions.
When your facility undergoes an FDA FSVP inspection and you do not have a compliant FSVP, an enforcement action will be given. Avoid costly actions and bring your facility into compliance today!
Are AMAZON sellers required to comply with the FSVP Rule?
Yes, absolutely! All sellers of imported food must have a compliant Foreign Supplier Verification Program (FSVP). The regulations for FSVP apply to Amazon sellers too. The process for compliance to the FSVP rule is the same for Amazon food sellers. If you are a seller of imported food products on Amazon, you must have a compliant Foreign Supplier Verification Program (FSVP). Import agents advertise services for FSVP, however, to be compliant with the FDA FSVP rule a qualified individual must develop and manage your program.
Contact us today to determine if your Amazon food business qualifies as an importer or very small importer. We will bring you into prompt compliance with the FDA and avoid costly enforcements.
Does not registering with the FDA ensure a food company will not be inspected?
If your company is not registered with the FDA it is possible to remain off the radar, so to speak. Typically, in these cases, the FDA is notified there is a facility importing food that is not registered with the FDA when they inspect a facility engaging in business with the unregistered facility, consumer complaints, or in response to a recall investigation. There are many ways the FDA could discover your facility without a valid registration.
If you are unregistered and are or planning to import food into the US, you must have an FDA compliant FSVP. Call us today to assist with FDA registration and determine FSVP needs. We will bring you into prompt compliance with the FDA and avoid costly enforcements.
What is an FSVP Agent and how do they differ from a US Agent in terms of Foreign Supplier Verification Program?
If your company does not have a physical entity in the United States, you may be required to hire an FSVP Agent. An FSVP Agent is solely responsible for compliance with applicable FSVP regulations as well as providing a valid DUNs number to file prior notice into the US. Your FSVP Agent will serve as a liaison between the US government and other regulatory agencies and your importing business.
A US Agent is typically an agent to a domestic business and is solely responsible for communications and does not have any responsibility for regulatory compliance of their clients.
For more detailed information on FSVP Agent services visit our sister company's website: https://www.fsvpconsulting.com
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