미국식품 FDA전문-Jay Lee (J&B Food Consulting)

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:

• Citation
• Form 483
• Warning Letter
• Injunction

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.