#FSVP Agent

[moussezi]

FDA Registration and Compliance Services

Unlike other companies offering FDA Registration and Compliance Services, ITB HOLDINGS LLC does not charge a separate fee for U.S. Agent.

ITB HOLDINGS LLC 390 North Orange Avenue, Suite 2300 Orlando, FL 32801 United States T: +1 855 389 7344 T: +1 855 510 2240 T: +44 800 610 1577

https://www.fda.itbhdg.com/product/fsvp/

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FSVP final guidance for importers published by FDA

The publication of such a document by the US FDA is timely since we are noticing increasing enforcement of the FSVP program. Warning letters issued by the FDA report weekly cases of unauthorized FSVP importers. The document is very useful also in the initial part, where the field of application of FSVP and all the definitions and roles are clarified (e.g. importer, owner, consignee, US agent…

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A Look Into The Requirements For The Foreign Supplier Verification Program

Under the FSMA (the Food Safety Modernization Act of 2011), in the United States, certain importers have taken the responsibility of developing the Foreign Supplier Verification Program.  Under this program, the primary aim is to create a food safety system. A food safety system ensures the prevention of food contamination and making the food free from food hazards if any. This program has laid down the rules for preventive checks and controls for manufacturers that manufacture, pack, or hold the animal and human food. It also maintains science-based standards for crops and produces grown on the farm. The Foreign Supplier Verification Program Rule affects the import community the most. An FSVP agent is hired to verify whether the foods that are imported to The United States meet the standards set by the program. The mission of this program is to ensure the food that is produced should be manufactured keeping in mind the safety regulations and offer protection towards public health and it is safe for consumption.  The food should also be free from any contamination, adulteration and misbranding.

Who is Covered Under this Program?

Under this program, any person who is the consignee or owner of the food of The United States is the FSVP importer.  It can be a person who owns the food, or has bought it or has agreed by signing an agreement to buy the food at the time of entering the United States. In case, if there is no consignee or owner during the time of making an entry, then The U.S. representative acts as the FSVP importer of the consignee which is generally confirmed through a signed agreement with the consent of everyone.  The aim is to have an FSVP importer in the United States who can take care of the things that are required to be met under this program.

The Requirements under FSVP: If you are an FSVP importer, then you have to perform the following functions:

Get in touch with a qualified person to develop the FSVP Rule and perform the FSVP duties.

A hazard analysis is required to be performed. You are required to identify the known and foreseeable hazards in each type of food and act accordingly.

Some potential hazards are chemical hazards, radiological hazards, biological hazards, food allergens, and nutrient deficiencies and physical hazards like glass.

You need to find out the risk associated with each type of food and apply food safety practices and hazard control measures.

Analyze the food safety performance history and the results from testing and audit.

Hire a qualified auditor to perform annual onsite audits to ensure the food is safe, and there are no hazards associated with it.

Testing and Sampling of food at regular intervals and take other appropriate measures.

Re-evaluation of the food and the foreign supplier every three years is also made mandatory.

Some food and beverages like juice and seafood are exempt from FSVP.

       Read through the above requirements and be informed about the FSVP rules and regulations.

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A Definitive Guide To FSVP Audits

To create a guide about the FSVP Audits we first need to answer questions about what it is and who it impacts and how. 

FSVP stands for foreign supplier verification program which is initiated and maintained by the Food Safety and Modernization Act. This rule is applicable for mostly the US food suppliers who are required to undergo the FSVP audits, and the US requires all food suppliers to be compliant to the FSVP rules and requirements. Either FDA or other third-party members are responsible for undertaking the audits and thoroughly checking the food suppliers and their systems to ensure food safety. 

There are certain deadlines in place before which all companies need to be audit ready and prepare themselves for the rigorous checking procedures. (Mostly the deadlines occur in May for large businesses and March for smaller businesses). All FSVP compliant companies must be audit ready by these deadlines in order to avoid serious consequences and to ensure that they can smoothly continue their food supply business. To do this many big and small companies take up the help of FSVP agents who help them with the process of becoming audit ready. Defining FSVP 

We have already defined FSVP in a preliminary manner, and now we shall observe the primary objectives of what it entails. It requires all US companies and food suppliers to take a percentage approach to food safety and demands them to undertake methods like hazard prediction and analysis and also strict or rigorous supplier verifications. All of this is can be put under the umbrella of working to provide food safety for the public that is the main aim of the FDA. Being Audit Ready And What It Entails: 

Activities regarding supplier validity and hazard analysis procedures

Companies that import foodstuffs are responsible for analyzing their suppliers and keeping a solid knowledge of known or predicted hazards and hence a system to counter such hazards and prevent damage from occurring. This entails an in-depth analysis of the extent and type of risk followed by corrective actions like in-house audits or supplier audits if necessary. Such companies should also ensure that the safety requirements and practices of their own companies are met with at their foreign supplying companies or other involved parties as well. There should also be transparency in the procedures and in-house audits or corrective measures which can help them ultimately be audit ready.

Transparent and rigorous record keeping 

As per the rules under FSVP, any company may be asked to produce records for any period of time between now to two years back, and it must be produced in as much as 24 hours time. To this policy, digital record keeping and strict practices can ensure that your company is always prepared and ready to respond to any such information summons. Another critical priority is keeping of the hazard analysis details and supplier verification processes. In short, all information should be easily accessible and well organized in order to be made accessible by the company as per the demands of the FDA or the FSVP audits. 

Auditors can ask for any such records and any company under this act is responsible for providing answers. Thus, it is best to be prepared and maintained proceedings as per the demands of the FDA in order to avoid serious or unpleasant consequences. 

FDAbasics aims at providing assistance to multiple foreign companies towards selling medical products, devices, and others easily.

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FDA U.S. Agent

What an FDA U.S. Agent is not?

Commercial Agent Customs Broker Initial Importer Importer of Record FSVP Importer

ITB HOLDINGS LLC

390 North Orange Avenue, Suite 2300

Orlando, FL 32801

United States

T: +1 855 389 7344

T: +1 855 510 2240

T: +44 800 610 1577

https://www.fda.itbhdg.com/u-s-agent/

[moussezi]

FDA U.S. Agent

What an FDA U.S. Agent is not?

Commercial Agent Customs Broker Initial Importer Importer of Record FSVP Importer

ITB HOLDINGS LLC 390 North Orange Avenue, Suite 2300 Orlando, FL 32801 United States T: +1 855 389 7344 T: +1 855 510 2240 T: +44 800 610 1577

https://www.fda.itbhdg.com/u-s-agent/

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The Aspects Of The FSVP Regulation

The FSVP regulation aligns with key components of the food safety plans that facilities that manufacture, process, pack, or hold must establish and follow under the preventive controls requirements in FDA’s preventive controls regulations