Food Registration Process For The Fda
Under the terms of the US Bioterrorism Act of 2002, every company that sells food, beverages, or dietary products in the US are all required to register with the Food and Drug Administration (FDA).
GHP Consultants provides a low-cost FDA registration service that is aimed at assisting food facilities to fill out FDA registration form online. This helps to avoid problems with inaccurate registration, which might cause troubles during events like customs clearance or FDA inspection of the food facility. We accomplish this objective by:
Ensuring that the FDA Registration is kept current at all times as well as when necessary
Ensuring that the registration is in alignment with the business activity
Offering the customer a private Certificate of Registration as a service .
When you register with the Food and Drug Administration (FDA), you are required to agree to let the FDA inspect your facility. This is done so that the food safety and bioterrorism requirements outlined in the US law can be evaluated for compliance. By registering with the FDA, you are required to accept that the FDA may visit and inspect your facility, and you are also expected to agree to make any necessary adjustments to your processes or products should the FDA order you to do so. During such an event, the FDA could allow the food facility to respond to the observations enlisted in the FDA form 483, or they could issue a warning or suspension depending on the seriousness of the non-compliance.
Who Must Get Their Products Registered With The Fda?
The FDA registration is required for both domestic and foreign facilities that are engaged in manufacturing/processing, packing or holding of food for human or animal consumtion in the United States.
The Food and Drug Administration will benefit from this in that:
Find out where a potential act of bioterrorism is taking place and where it is coming from.
Find out where an outbreak of food-borne illness is occurring and what the source of the outbreak is; and
Notify the impacted parties and the facilities as soon as possible.
To recall the non-conforming products effectively
In the event that the FDA determines that a product or products manufactured, processed, packed, received, or held by a registered facility have a degree of probability of causing serious adverse health consequences, any harm or fatality to humans or animals, the FDA may suspend the registration of a facility that meets the following criteria:
constituted, was primarily responsible for, or in any other way contributed to the existence of such a reasonable possibility; or
have knowledge of, or had cause to believe they possessed knowledge of, such a reasonable probability; and also packed, received, or held such food not complying with the GMP or FSMA regulations.
Registration Agent
During the process of registering with the FDA, you will have the opportunity to provide information regarding an appointed Agent who will communicate with the FDA on your behalf. Additionally, it is possible that you will be required to have a Foreign Supplier Verification Program (also known as an FSVP) in place. Both your Registration Agent and your FSVP Agent responsibilities can be handled by GHPConsulting and Testing LLC.
Assigning Responsibilities To Multiple Entities
Producing a food, beverage, or dietary supplement product typically requires the involvement of more than one facility. In many instances, this may be the case. For instance, a processor might perform bulk processing and then send the product to a packer, who would then pack and label the product with either their own brand or the brand of a third-party owner of the brand. In situations like these, having a clear understanding of who needs to register with the FDA is essential.
Who Is Required To Register With The Fda?
GHP’s FDA FSMA consulting team is comprised of industry-leading FSMA and import-related experts who are proficient at assisting clients to develop a food safety plan and bring FDA compliant food products to the US from foreign countries. Our team will help your company to reduce the risk of any non-compliance and get you ready for FDA inspections. To ensure that compliance is not a barrier to trade, we have made significant investments in core operations. These investments have enabled us to streamline and automate the procedures of paperwork and assessment to help us manage our client documentation when we are assigned as the responsible entity or agent.