Services

HYKKON Global logistics will assist throughout the process of all imported products which must meet the same standards as domestic goods. Imported foods must be pure, wholesome and produced under sanitary conditions; drugs and devices must be safe and effective; cosmetics must be safe and made from approved ingredients; radiation-emitting devices must meet established standards and all products must contain informative and truthful labeling in English. In addition, all products must conform to complex laws regulations relating to their labeling.

Plant Visit/Inspection

HYKKON’S Global team can arrange all required plant and product inspections, to certify compliance with safety and quality standards.

Quality Assurance

HYKKON believes quality assurance is vital to protecting the reputation of your brand and company. Our team can help to insure that you maintain the highest possible quality standards.

Pre-shipment Inspection

HYKKON will assist you with pre-shipment quality inspections to insure your compliance with all applicable regulations and the expeditious delivery of your goods.

Import Prior Notice

There are requirements that apply to all imported products  foods beverages,dietary supplements and ingredients with some conventional  foods imported drugs and medical devices.

Before any transaction is made the importer agent owner or consignee of the shipments must submit  Prior Notice with information about its manufacturer before it arrives in the USA.

Failure to provide a Prior notice will create a importers Detention and consequently a Refusal of Admission to USA from FDA.

The importer or agent must respond to FDA detention Notice. Also there are other agencies who can and will be involved in this detention such as U.S.Custom hold, USDA manifest hold or Emergency Action Notification.

It is necessary to identified the agency and present respective legal regulatory assessment to that particular agency seek  the reason and  provide adequate solution to satisfy this violation with that particular agency.

It is important that all importers,manufacturers and all agents,shipper involve must and should prepared for this events to avoid hold and or at least reduce the length of delays.

HYKKON Global Logistic Group  will assist importer and manufacturers follow proper compliance and provide advice on their products, labels and record keeping all permits and certificates before reporting to U.S. We will follow the process and in the event of a hold provide all necessary documents to expedite release of products.

Imports Holds and Detentions

This process can affect Importers  manufacturers,agents and consignees. FDA holds can take from weeks to months especially when each agency involved use their jurisdiction right to examine, inspect and sample or review documentation of imported products. These delays can cause importers to miss schedule delivery and affects accounting that can mount up to large fines and  fee charges.

All products that are imported and get to US customs Border Protection entry level has already conditionally release to the importer must  still wait to resolve  FDA release before it can get to the distributor of U.S.Commerce at which point  the importers cannot distribute any goods or products until it is inspected by FDA only because they have the right and jurisdiction to recall for any additional inspection.

FDCA and FDCA Detention Authority

These Agency have the right to detain any food or product that appear to be in violation of any rules and regulation or compliance.   FDA will send notice of detention to the importer, agent, Owner or consignee and customs broker. This notice will advise all parties involved of the Violation. And at this point they will be advise that they entitled to an informal hearing granted by law. The party responsible must share a testimony of proof that product is in compliance.  Also it is important to submit a plan that show how product will be in compliance.

Failing to do so will result in a notice of Refusals and admission of goods and products.

It is important to solve all import detention when is at this stage.   HYKKON Global group will assist companies importers get a release before it gets to the Refusal of Admission level because it is more difficult to get this resolve. The reason is very simple, it is very critical to have FDA reverse a decision of reversal of a Refusal of  products or goods into US market.

When a Detention occurs FDA grants limited amount of time to correct or to prove to FDA  that the violation was wrong or corrected.  That is why it is necessary to to act and correct a violation at the Notice of Detention level so it can be resolve. This can be very costly if it is not handle immediately.  There are ways to solve FDA Detention and adhere to compliance, you can request an opportunity to resubmit your application relabel and recondition the product.. At that point FDA will verify that process was corrected sending an inspector. If it meets approval you will request a release so the products can be send to marketplace.

FDA Alerts

FDA call an import alert list that are used to provide notice to all district offices and compliance officers of an importer, or foreign manufacturer and its products to be in violation of FDCA or FDA rules and Regulation.  In most cases these firms are placed on this list will face automatic Detention without physical examination (DWPE).

As for foreign companies or manufacturers   it is important they follow all rules and regulations and exercise compliance to not find themselves and this Import Alert List.   Because they will face challenges when  trying to import into U.S Market.

At HYKKON we are committed to work with importers and manufacturer assisting them in obtaining an exemption or removal from this Import Alert or Detention LIst.  Any firm who find themselves and this List will find it very hard to do business or compete in the USA market. Because FDA Publishes  its Import Alerts list on the internet and can be viewed by customers and potential customer and this can make  companies vulnerable to DWPE . We will assist companies and make sure they follow rules and stay in compliance with products and documentation.

FDA have different types of import alerts  where they instruct inspection, investigation and also compliance officer to detect and detain product from companies, manufacturers, shipper and growers of a particular geographic area and in some times  a country and according to products or a combination of both and that create and international barrier for that commodity.

HYKKON will assist and represents companies of food, drug, cosmetic and medical devices before the respective agency and will seek to remove your companie manufacturer from that problem alert list.

Its is always measure of caution if the product is obtained from a third party country or shipper who is not authorized to ship to USA.  In such cases manufacturers and companies who are on the alert list after its being ship to a distributor in USA and find out that it is on the FDA detention list. There are more than 150 differents FDA import Alert there can and will affect a great amount of Manufacturers,Shipper or Growers and Importer and include some countries.

HYKKON will assist companies to make sure they are in compliance.

FDA Refusals

When FDA import detention is issued the agency must provide the importer owner, consignee or agent with a notice notice  explaining that specific violation. FDA will also provide the opportunity to the respondent (importer or manufacturer) consignee or agent, to provide a response to correct the violation.

In the event that the respondent fail to answer and correct the FDA detention Notice there can and will be a Notice of import Refusal which means the respondent must destroy or re-export the product within a reasonable period of time 90 days after violation was issued.

Whenever a shipments has been subject to FDA import Refusal. US. Custom Border Patrol (CBP) will demand that the shipment be re-delivered to their custody.  And when this occur CBP will issued a form 4647 for redelivery.  Even though this is not done in every port of entry there are times when Customs will just stamp the FDA import of refusal Notice. And this notice become custom redelivery importer of record who have placed the import bond for US custom on this shipment. The importer can comply on demand of destroying or redelivering the goods.

Under US custom supervision or FDA.  In the event that this measure is not met and merchandise is not destroyed within  a reasonable timeline the importer will be fine by U.S.Customs an amount equal to three times the value of the refusal merchandise up to the cost of import bond for that shipment or goods.

Managing and FDA import Refusal is a very difficult Task even though it is not of a normal occurrence. Trying to resolve this issue depends on the facts related to this shipment sar products also the way Fda handle this process at time of arrival to USA and how and when the FDA issued violation of notice to the importer or whether the information supplied to importer or Broker to FDA to resolve this detention or see  if FDA is correct in its interpretation of rule and law concerning this Violation.

There are various option that importers can use in the event that an importer products or shipments is refused admission by FDA.

For example the Bioterrorism Act 2002 (BTA)  which clearly express that the reimportation of food that are issued on a Notice of Refusal FDA can be permitted to reapply for entry once it establish foods or shipments comply with relevant provisions rules and regulations.

Hykkon Global Logistic Group Will assist company re-import foods that were incorrectly refused admission  help to the importer comply with FDCA and FDA rules and Regulation.

Import Procedure

Importers must and should make sure that all products imported to USA must meet FDA-CBP US Customs Border Patrol.   If an examination is conducted and food samples, product adulterated, misbranded, unapproved by FDA will detain the product once it arrives in the USA, importers must present evidence and proof to FDA.  If these do not meet the criteria they will be issued a Notice of Refusal or Admission of products and these will consequently will be ordered to get destroyed or exported back to its origin within 90 days of violation.

Customs Entry And ITs Process

When importing into the USA the Importer or Custom Brokers must submitted a custom entry detailing to local port of entry or custom office.  These entries are filed electronically to FDA database for review this will need presentation of certain commercial documents related  to this shipments. And if there is a need for more information they will make a request to the Broker or Importer.  And this process is not uncommon for FDA to look or request more info from the Importer Shipper Foreign Manufacturer or Custom Broker to verify compliance with rules and regulations.

When making an entry declaration the information must be clear, a product by Customs Harmonized Tariff Schedules Codes  according to Codes in the USA and FDA products Codes that are very different from each other.  Most brokers will assist when classifying imported products according to HTSUS and also many may require that importing clients provide  FDA products Codes.  Importers and others must be very careful when providing classification of Codes because if this process is not done correctly it can create miscalculated customs duties and these likewise can result in fines.

Customs entry declaration and FDA must include information about Importer of record, foreign manufacturer and shippers and consignee  about the quantity and value of products with the appropriate description these are all subject to specific regulation issued by US Customs and FDA. and FDCA that also require a registration number of foreign food, drug, medical device must include when filing Prior Notice.

For canned foods establishment (FCE) number and the schedule process identification number (SID)

Custom Classification

Every importer  of record duty is to properly classify their products codes (HTSUS) it is important to use reasonable care when classifying foods and goods. A product not classified properly will cause delays and probably the possibility of a seizure that can cost the importer fines and penalties.

It is important to know that (HTSUS) classified codes affects how federal agency regulate and treat products, that is why it is important to correctly classified products these can cause unfavorable inspection or entry review by any agency FDA, USDA, (TTB) or for Tobacco Products Code.

How to Maintain Good Record Keeping

According to custom Bioterrorism Act (BTA) and FDA regulation issued under BTA there are certain specific products (seafoods, canned foods, medical devices and electronics products) and few others.  Importers, Owners, and consignee of products. Must maintain important record keeping when it come to distribution storage and additional processing of transportation of these products.

It is important that the Importer maintain good record keeping  failing to follow these regulations established by the Federal Agency can and will result in administrative, civil and may even mean at times criminal enforcement action.  Nevertheless, on very few occasion criminal cases violation are issued to parties trying to defraud the government.

At HYKKON we will work with Company, Importers and Manufacturers to maintain and comply with good record keeping with all agencies involved in the importation of products and goods.

IMPORT FOR EXPORT

There are provision when it come to FDA Import for Export (IFE) and often misunderstood by the import community and at times by government officials.  Custom brokers and importing FDA regulated products seems to have a better understanding of (IFE) provision and subsequently will have an advantage in knowing when the IFE applies to them and how to file an IFE correctly.

They also know how to avoid any problem when custom entry type when filing with FDA.

Some importers make the mistake to use IFE custom entry type such as IE (Immediate Export). And as a matter a fact, IFE is an entry type that legally exempt from FDA refusal and FDCA and is subject to certain criteria.

At times, there are some provision by FDCA that allow importers to ship certain articles that are in violation of FDA rules and it also allow importers to incorporate these items into another article and then re-export these items.  The only products that can be declared as (IFE) are drugs and other components, food additives, dietary supplements, color additives and biological products.  It is important to note that conventional foods and cosmetics cannot and will not be accepted as IFE Items.

The IFE article may include Labeling, Packaging, Sterilization and other activities this article imported cannot be an item by itself and incorporated as IFE.  It only can be an entry for storage purpose.  But if for any given reason this article is imported it must be incorporated to food, food additives, drug color additives, dietary supplement or any biological product.

This when performed it must be done by owners or consignee of the goods. If there are any  portion of this item that was not exported it should be destroyed by designated owner.

Some process are done by FDA that may release entry group receipt if all necessary documents required for an (IFE) even thought  IFE entry are exempt from FDA refusal that does not mean they are exempt from FDA detention . There are confusion when mistakes are made and the then FDA detain an IFE entry and hold it until the importer gives FDA proof that the article has been re-exported again and that include BL (Bill of  Lading) and all customs forms for exportation.

Once FDA receives all documents needed it will release entry subject that it meets all criteria required to avoid further detention or refusal of entry of article.

An FDA  refusal can cause Importers, Shippers, Manufacturers and its products to be place on the Import Alert List this will cause that future shipments from this company to be automatically detained by FDA  and at times even if a company is not place on this Import Alert  it will create an avenue of increased inspection and examination of products. FDA may not allow as non-IFE entry to further incorporated into other articles.

FDA ENFORCEMENT  (FDA Inspection)

Because this system is so complex it is important to follow all rules and regulations.  More so to understand the process.

Congress has granted authority to FDA when it comes to inspecting any and all establishment Manufacturers, Packaging, Foods, Drugs, Medical Devices, Tobacco products or Cosmetics for interstate distribution. This process is also limited to pharmacy it is important for any company to allow FDA to inspect.   And all this should be done within a reasonable  time and manner.  Any company who refuse FDCA to inspect will be  in Violation.

Every company have the right to receive a notice of inspection and also able to verify that the Inspector is indeed an FDA employee and at this point have the opportunity to explain concerns during inspection, all companies  should and  can make all necessary correction when violations is determined by FDA  and noted on FDA Records.

HYKKON professionals will assist companies in the event of an inspection to make sure you understand your rights.  During this inspection companies should always be ready and with HYKKON on your side we will make sure your facilities are ready for inspections.

FDA/ENFORCEMENT AND WARNING LETTERS and 483S Forms

Once FDA has completed an inspection of any facilities they will have a meeting with management to discuss the finding and all objections and conditions .

Company representative have the right to ask and question all objections depend on what the inspector respond he or she can issue  and FDA Form 483s describing all his finding.

The company will get some time to correct  and address all issue to comply with rules and regulations.

When FDA receive a response from companies facilities about the Form 483s that explain  the nature of effect to the safety of consumers. FDA  may proceed and issue an Warning Letter to the respondent (the company or facility) the agency will set a timeline in which company can respond to warning letters.

These warning letters are public documents from the moment they are issued until they are published on FDA website this agency is committed to regulate all aspect and process of any and all facilities.  Sometimes this agency will issue an untitled letter.

FDA expect that a company that was issued a violation must respond to form 483s, Warning Letters, and Untitled Letters.

The response must address the agency concerns and explain method of corrections and show means of improvements that will be implemented in its process.

HYKKON will assist companies to make sure the facilities meet and comply will all agencies requirements  and follow rules and regulations.

The BTA expanded FDA’s authority with respect to foods through several specific areas of new FDA regulatory and administrative power:

1. Registration of food facilities with FDA (foreign and domestic) is required under the BTA.
2. Prior notice of virtually all imported food shipments under FDA authority is required under the BTA.
3. Record keeping requirements for food facilities (to include transporters of food in the U.S. and International carriers bringing food into the U.S.) were established under the BTA.
4. Authority was granted for FDA administrative detention (not import detention) of food if FDA has credible evidence that such food presents a threat of serious adverse health consequences or death.
5. Authority for FDA to institute debarment of food importers of various violations related to food importation.
6. Creation of a clear way to re-import previously refused foods if certain criteria are met.

FDA has implemented four of the major BTA authorities by promulgating bioterrorism regulations related to FDA Food Facility Establishment Registration, FDA Prior Notice of Imported Foods, FDA Administrative Detention, and FDA Record Keeping requirements related to foods.

HYKKON and affiliated attorneys regularly provide guidance and representation with respect to all aspects of the BTA, FDA’s implementing of bioterrorism regulations, the agency’s bioterrorism security guidance for food, cosmetic, drugs, and biological products establishments and their respective products.