What is FSVP? Everything You Need to Know

What is FSVP? Everything You Need to Know

 

What is FSVP?

what is fsvpFSVP is the international trade law that has been passed under the Food Safety Modernization Act (FSMA, read more about it here.) FSVP is known as the Foreign Supplier Verification Program. This is a set of programs that are in place to validate and verify that our food safety standards are being upheld.

The purpose of FSMA is to put as many preventative measures between infected food and consumers as possible. With expansions already in place for food production and food growers, the next focus is on importers, which is where FSVP comes in.

What Kind of Imports are Affected?

Food exclusively. If you are a food importer with the intention of reselling the products, you will have to abide by FSVP standards.

How does it affect my Job?

As an Importer, the rules of your job are now expanded. You now have two additional tasks that need to be obeyed.

fsvp trade inspectionsYou must be Food Safety Ready – The concept behind FSVP is that warehouses, where food comes in, should be held to the same standards as restaurants and supermarkets. You must now follow similar food safety rules. For Example, in New York, it is required that all food surfaces and storage spaces be at least 6 inches off the ground at all times, New York Warehouses must now abide by this law as well.

Your Overseas Partners are Food Safe – Once you have declared your warehouse ‘food, safe, and ready,’ you must now begin vouching for your importers. You are required to inspect the delivery methods and the state of the food when it enters your warehouse and communicate this information to the FDA and your trade partners.

A1WWL

If you are finding it difficult trying to determine if you need to be FSVP compliant or if you are having trouble becoming FSVP compliant, give us a call. We are working closely with the government to ensure that your imports are affected as little as possible, and we can help you out! Call us today!


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How to Prepare for FSVP Inspections

How to Prepare for FSVP Inspections

 

What needs to be done to be FSVP Compliant

When you are working to be FSVP Compliant, you need to follow these three steps.

fsvp inspection1) You need to talk to your customer and supplier to protect your assets and relationships.

2) Register with the FDA to expand your relationship with the government and formulate a food safety program

3) Register to be GSFI certified.

Communicate with your Supplier and Customer – Most people are still unaware of the fact that FSVP is already taking effect. There will be slowdowns, and there will be hiccups as we are all adjusting to this new system. The sooner you convey this to them, the easier the transition will be.

Register with the FDA – Next you will want to register with the FDA. By joining the system, it shows that you are making the positive steps to represent these changes.

Formulate a Food Safety Program (GSFI) – Next you will want to develop food safety routines based on existing protocols. Contact local supermarkets and ask them how they handle their warehouses. Next, you need to be certified by the Global Food Safety Initiative. Becoming Certified will prepare you for any question asked during an inspection.

What to do During Inspections

When an inspector arrives at your warehouse, it is important that you understand the inspector’s intention. Their job is to examine and report to their superiors, but more importantly, they are there to inform you.

fsvp compliantTake Notes – Take notes of everything they do. They are going to be giving you all of the answers so take this information and apply it to your existing program.

Ask Questions – Whether you are questioning the process or looking for tips to improve your plan, asking questions is a great way to get better information and possibly save you money.

A1WWL

If you are finding it difficult trying to determine if you need to be FSVP compliant or if you are having trouble becoming FSVP compliant, give us a call. We are working closely with the government to ensure that your imports are affected as little as possible, and we can help you out! Call us today!


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How to Enforce FSVP with your Exporters

How to Enforce FSVP with your Exporters

 

Personally Inspecting the Food Products

enforce fsvp with exportersNo matter where the products come from, two steps must be followed every time: First, the Importer must assume the role of an FSV, next they must follow the ACE system.

The Role of an FSV – The role of an FSV simply means that you are following the protocols of a Food Safety Verifier. Since you maintain a warehouse that is FSVP compliant, you must now take the standards that you have passed and assert it onto the food products being brought in.

The ACE System – Automated Commercial Environment is the official system through which the trade community reports imports and exports. Once you have inspected the products, you must log one of three codes for the products: FSV, FNX, or RNE.

If the products are compliant, you will mark them FSV*. The products will continue through their import process and be distributed as such.

What happens if the Products are not FSVP compliant

There are two classifications to follow through once food products are not considered compliant, they are either dubbed FSX or sent to RNE.

CarrierFSVP Exempt (FSX) – Food products that are dubbed FSX do not necessarily need to follow the FSVP guidelines. These can be anything from foods that aren’t held to the same standards, to food that is held to higher standards. For example, Cans are sealed and presumably boxed and withheld, with the exemption of damaged goods, canned foods are by default FSVP compliant and would be parsed through a different branch of FSMA for further inspection.

Research and Evaluation (RNE) – Additionally, if something is not completely FSVP compliant, they could be passed to RNE or Research and Evaluation. When this happens, they inspect whether or not the food is still passable and able to be distributed for healthy ingestion. Depending on how the food is processed, it could be sent back, or it could be distributed under a limited exemption.

Read more about the FSVP guidelines here: https://www.fda.gov/Food/GuidanceRegulation/FSMA/ucm556661.htm

A1WWL

A1WWL takes being FSVP compliant very seriously. As part of the Food Safety Modernization Act, there is a lot of information to go through, and we hope that this guide has helped you understand the ins and outs of the FSVP process. IF you would like to learn more about FSVP or how we can help you pass your products through customs easier, please give us a call today!

Special Notes

* – When FSV entities are transmitted to ACE, the following data is required:
• DUNS Number
• Firm Name
• Firm Address
• Entity Role of FSV
• Email Address


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What happens to Decommissioned Container ships?

What happens to Decommissioned Container ships?

 

How are Container Ships Commissioned?

Ships are commissioned for work after they have been rigorously tested and inspected. This can be anything from warships being dubbed battle ready or cargo ships shown to be structurally sound. These tests are known as sea trials and are used to identify deficiencies that would need to be fixed beforehand.

How do they become decommissioned?

Ships become decommissioned over time because the sea takes a heavy toll on the structure. This is usually determined when they come to port, and they are inspected. Think of it as a pit stop during a high-speed race, they will see how long it takes to bring the ship back to working order and eventually those repairs will become too costly and thus cargo ships are considered decommissioned.

What happens to them?

There are a few creative ways that cargo ships become decommissioned.

decommissioned cargo ships Cargo Reefs – In Texas, it is incredibly common to take old cargo ships and sink them so they may become artificial reefs that sealife can go and live in. The most famous one of these have been known as the Kraken and was featured in a video dubbed ‘Release the Kraken.’

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Importing Medical Devices

Importing Medical Devices

Why does it matter?

There are two important points to know about when importing medical devices. First, medical devices must comply with every standard of normal importation except you must also file the belongings in what is known as an MDR. Second, if the medical devices import radiation, there is a completely different process that you need to adhere to.

How to Import Medical Devices

Firstly, the manufacturer you are importing from must follow American regulations before they can be imported to the country.

Checklist of Foreign Regulations:

  • Registration of Establishment
  • Listing of Devices
  • Manufacturing in Accordance with Quality Regulation
  • Medical Reporting of Adverse Effects
  • Premarket Notification 510(k) [Premarket Approval]
  • U.S. Agent Designation

medical devicesAll of those must be strictly adhered to as a foreign manufacturer. But if you are an importer, the main change you must make is to follow an MDR filing.

Medical Device Reporting: The Form FDA 3500A is a report that the importer must have on-hand and report from the manufacturer. This report details reports of deaths or serious injuries as well as malfunctions associated with these medical devices.

You can read more about Medical Device Reporting here.

Radiation

When a medical device emits radiation, it must follow-through a separated process from the typical importation. You must specifically follow the FFDC Act (Federal Food, Drug, Cosmetic Act) Subchapter C- Electronic Product Radiation Control.

Following these standards means you must follow these requirements.

importing medicalPerformance Standards – How much radiation will be emitted and how efficiently it is capable of doing so.

Proper Labeling – Contents of the device, what type of radiation is emitted and how many quantifiable units could be irradiated from the device.

Radiation Safety Reports – Detailed reports about how to properly handle the radiation and how strong the radiation could be.

Read more about the Electronic Product Radiation Control here.

A1WWL

With A1WWL, we work to remove as many hurdles between you and your products. If you want a smooth import of your medical devices, please give us a call before beginning the transition, we could save you a lot of headaches and setbacks between you and accessing your device.


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