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Under the FDA Foreign Supplier Verification Program (FSVP) rule, most U.S. importers must develop FSVPs to provide adequate assurances that their foreign suppliers are producing food in compliance with processes and procedures that provide at least the same level of public health protection as those required under section 418 (Hazard Analysis and Risk-based Preventive Controls) or section 419 (Standards for the safe production and harvesting of certain fruits and vegetables that are agricultural raw materials), if applicable.

Produce food in accordance with sections 402 (with respect to adulteration) and 403(w) (with respect to the labeling of human foods for the presence of important food allergens) of the FD&C Act.
The FDA will hold the FSVP importer responsible for complying with all requirements of the FSVP rule.
If an importer fails to develop an FSVP, has an incomplete FSVP, or fails to reevaluate its suppliers as needed, the FDA may take enforcement action. According to § 1.514, the products will not be admitted to the USA and in case of being in the USA their commercialization is prohibited.
If you are an importer in the USA of food products.
We have a team of professionals ready to offer solutions to the complex regulation and standards that the new Food Safety Modernization Act (FSMA) bring.
Along with instructors, lawyers, and auditors, we will help you, your company, and your suppliers from South and Central America fulfill all the requirements.
We train your staff, carry out the programs required by FSMA, or carry out a Verification Program for Foreign Suppliers.
We solve all your problems so that you import food products to the USA, complying with FDA regulations.
That is from the very beginning all the way to the end.
If you are a food exporter to the USA.
We solve your food export problems and compliance with FDA regulations.
Including an audit of the FSVP Compliance Diagnosis.
We are ready to assist you so don’t hesitate and contact us at once.
With over 30 years of experience in the food business our professionals the on-hand knowledge on how to deal with this new demanding regulation. We have offices in the USA and South America.

What is FSVP ?

Final Rule on Foreign Supplier Verification Programs

The FDA Food Safety Modernization Act of 2011 mandates the creation of a food safety system in which the focus is on preventing contamination rather than primarily reacting to problems after they occur.
 The FSMA rules include those that create preventive controls for the production of human and animal foods, and establish science-based standards for produce grown on farms.
The import community will be most impacted by the Foreign Supplier Verification Programs (FSVP) rule, which requires FSVP importers to verify that the food they import meets U.S. safety standards.
The goal is to ensure that each food is produced in a manner that provides the same level of public health protection as the preventive controls and produce safety regulations, if applicable, and the food is not adulterated or misbranded with respect to allergen labeling.

FSVP is a program that importers covered by the rule must have in place to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, as appropriate, and to ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling.
The specific responsibilities of importers with respect to food safety include:
Determining known or reasonably foreseeable hazards with each food;
Evaluating the risk posed by a food, based on the Hazard Analysis, and the foreign supplier’s performance;
Approving suppliers and determining appropriate supplier verification activities based on the risks posed by an imported food and the supplier’s performance;
Conducting supplier verification activities; and
Conducting corrective actions for deviations and discrepancies. The appropriate corrective measure will depend on the circumstances, but could include discontinuing use of the foreign supplier until the cause of noncompliance, adulteration, or misbranding has been adequately addressed.
Importers must establish and follow written procedures to ensure that they import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food and the supplier’s performance or, when necessary on a temporary basis, from unapproved suppliers whose foods are subjected to adequate verification activities before being imported.
Importers are required to develop, maintain, and follow an FSVP for each food brought into the United States and the foreign supplier of that food. If the importer obtains a certain food from a few different suppliers, a separate FSVP would be required for each of those suppliers. Similarly, if the importer obtains many different foods, from a single supplier, a separate FSVP would be required for each food.
Certain importers that are also manufacturers/processors are deemed in compliance with most FSVP requirements if:
They are in compliance with the supply-chain program requirements under the preventive controls rules;
They implement preventive controls for the hazards in the food in accordance with the requirements in the preventive controls rules; or
They are not required to implement preventive controls under those rules in certain specified circumstances. Examples of such circumstances include when the type of food (e.g., such as coffee beans) could not be consumed without application of a preventive control, or when the customer will be significantly minimizing or preventing identified hazards) and they comply with requirements for disclosures and written assurances.
Unique Facility Identifier
The FSVP rule requires importers to provide the name, email address, and unique facility identifier (UFI) for each line entry of food product offered for importation into the United States.

FSVP Services

We have qualified people in Hispano América who will visit and control your suppliers to avoid all kinds of problems, by performing FSVP Programs for every supplier and product.

The following is what the law requires and are the services that we will provide:
We have qualified individuals in Hispano America that will provide you with the following services,
• Determining known or reasonably foreseeable hazards with each food • Evaluating the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance • Using that evaluation of the risk posed by an imported food and the supplier’s performance to approve suppliers and determine appropriate supplier verification activities • Conducting supplier verification activities • Conducting corrective actions, if it is necessary.
We are going to establish and follow written procedures to ensure that you import foods only from foreign suppliers approved based on an evaluation of the risk posed by the imported food and the supplier’s performance or, when necessary, on a temporary basis, from unapproved suppliers whose foods are subjected to adequate verification activities before being imported.
We are going to identify and evaluate by you—based on experience, illness data, scientific reports, and other information—the known or reasonably foreseeable hazards for each type of food it imports to determine if there are any hazards requiring a control. These include: • Biological hazards, including parasites and disease-causing bacteria • Chemical hazards, including radiological hazards, pesticide and drug residues, natural toxins, food decomposition, unapproved food or color additives, and food allergens • Physical hazards, such as glass, stones, hard plastic, and metals.
They may be hazards reasonably likely to cause illness or injury that occur naturally, are unintentionally introduced, or are intentionally introduced for purposes of economic gain, such as substituting a less costly ingredient. The analysis must assess the probability that these hazards will occur in the absence of controls and the severity of the illness or injury that could occur. The evaluation would have to consider factors that include the: • Formulation of the food • Condition, function and design of the establishment and equipment of a typical entity that produces the food • Raw materials and other ingredients • Transportation practices • Harvesting, raising, manufacturing, processing, and packing procedures • Packaging and labeling activities • Storage and distribution • Intended or reasonably foreseeable use • Sanitation, including employee hygiene.
And in addition, we will control the Food Defense programs following 21CFR121, the Mitigation Strategies law, to protect food from Intentional contamination.
And if your suppliers need training, we have Approved Instructors to give the official courses requested by the FDA, to create the PCQI for Food for Animals or Humans, to instruct those responsible for Agricultural Production Farms, and the FDQI that they must carry out Food Defense programs.
We can also teach the Better Process Control School courses for canned foods or airtight containers of high or low acidity.
Call us, and we will solve your problems, 20 years of work before the FDA guarantees us.
You take care of your business; we will ensure that the food you import is safe and healthy, complying with the same production standards required of companies based in the USA.
Avoid fines, suspensions, or being discharged as a food importer; a phone call will solve your problems.

This course will provide participants with the knowledge to implement the requirements of the “Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals” regulation of the U.S. Food and Drug Administration (FDA). This regulation is one of a number of regulations and guidance that implement the provisions of the 2011 Food Safety Modernization Act (FSMA), which focuses on safe food practices. This course is designed for:
U.S.‐based importers who meet the definition of “importer” in the FSVP rule, which includes those who own or are the consignee of food at the time of entry, or, if no owner or consignee exists, the U.S. agent or representative of the foreign owner.
Others who have an interest in ensuring that the requirements of the FSVP rule are met, including brokers, exporters, foreign suppliers of food that will be exported to the U.S., persons/business owners who currently buy food from foreign sources, and representatives of foreign governments.
The FSVP curriculum was designed by regulatory, academia, and industry professionals and developed with funding from FDA as part of the FSPCA. In contrast to the Preventive Controls (PC) rules, the FSVP rule does not require you to attend a training program following a “standardized curriculum” recognized by FDA. Attending this course, however, will help you understand the FSVP requirements and how those requirements can be met in your particular circumstance.
These courses are taught by Lead Instructors trained by the FSPCA, who have been instructed on how to teach the FDA-recognized standardized curriculum.

FDA Agents

FDA Registration of Food Facilities

To comply with U.S. law, all "Food Facilities" involved in the production, processing, storage or packaging of food intended for human or animal consumption within the United States must register with the FDA.
Any non-U.S. company wishing to market a food product in the U.S. must appoint a U.S. agent and register the facility.
The agent acts as an intermediary between the company and the FDA. We provide a full U.S. agent service for our foreign clients.
What are our services:
1) Food facility registration.
Food facility registration is one of the FDA requirements for food products.
If you are a foreign company or import food products manufactured in a foreign country, you must appoint a U.S. agent and register the facility.
FSQOrganization will act as the U.S. agent for food facility registration purposes and register the facility.
Please note that the FDA does not issue the food facility certificate and the certificate is not mandatory. You will receive the FDA food facility registration number by email. Our company can issue the food facility registration certificate for your reference.
2) Training
We will give our overseas customers a free place in PCQI Human or Animal Food or Food Defense courses (five courses).
We can also provide them with full training and the Food Safety Plan and Food Defense Plan programs.
3) Follow-up
Every month we will send you the data that the FDA has about your company and also the data of two other companies that you designate, to know, for example: suppliers or customers.
Labeling compliance
Product labeling is one of the most important FDA requirements for food products. We offer label review services at an additional cost. To review the label, you must provide us with the label design in PDF or image format.
Failure to comply with labeling requirements may result in incorrect product labeling and detention action.
3.Prior Import Notice
Prior to shipping goods, you must notify FDA of the arrival of your shipments with your customer by filing a Prior Notice of Importation (Prior Notice).
If you wish to file a Prior Notice yourself, we can send you step-by-step instructions that you can follow and submit the Prior Notice. At additional cost.
4) FSVP Agent or Importer
The foreign manufacturer must identify the importer for purposes of compliance with 21CFR 1.subpart L, or FSVP Act. If you already have an importer in the U.S., that importer is responsible for the verification responsibilities for the products you ship.
We can make the corresponding FSVP, which you will be able to deliver to all your importers, solving one of the major problems of exporting to the USA.
5) Good Manufacturing Practices and HACCP
We train companies in all the regulations that apply to them, a training of the company's choice is included in the subscription.
6) Performance of SID Numbers
All processors of low acid or acidified foods must undergo special training and register their processes under the respective SID Numbers. We perform both requirements.
Call us and we will solve all your food export problems to USA.

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