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Detention Assistance and Import Alert Updates

Facilities located outside the U.S. that refuse an FDA inspection may be placed on Import Alert 99-32: Detention Without Physical Examination (DWPE) of Products from foreign establishments refusing FDA inspection. Not only does this import alert allow the Administration to seize your items, it places your establishment on an FDA Red List. Any products from facilities added to the Red List are subject to refusal of admission according to section 807 B of the FD&C Act until the facility has documented proof of an inspection. What is an Import Alert? Import Alerts occur when the Food and Drug Administration (FDA) notices a pattern of non-compliance from a particular company, country, or product type. They inform both FDA's field staff and the general public that the Administration has enough evidence to permit DWPE of products that appear to be in non-compliance and violation of FDA regulations. Delayed or refused shipments resulting from Import Alerts and their respective FDA Red List can strain relationships with buyers, damage a brand’s reputation, and can greatly affect revenue. We strongly advise establishments to accept an inspection without hesitation. FDA may issue a Notice of Inspection at any time. You should prepare by assuring your facility is compliant with FDA Current Good Manufacturing Practices (cGMPs) and other regulatory requirements as other violations may warrant further field examination. What is the Purpose of an Import Alert? Import alerts are intended to help prevent products suspected of FDA violation from being distributed in the United States. They free-up agency resources for the physical examination of products from other shipments. Import Alerts also provide uniform coverage across the country. Import Alerts also place responsibility firmly with the importer. This is to assure that products being imported into the United States are in full compliance with all FDA's laws and regulations. What Types of Import Alerts Are There? A product can be placed on an Import alert based on how the product is made or based on issues with the product itself. Import alerts are usually categorized as: Country or Area Wide FDA may detain without physical examination various products intended for distribution in the U.S. from a specified country or area. For example: Import Alert 12-03, DWPE of Imported Soft Cheeses and Soft Ripened Cheeses from France. Country or Worldwide FDA may also detain without physical examination certain products from any and all countries outside of the U.S. for various reasons such as: Import Alert #16-20, DWPE of Puffer Fish. Due to the fact that the toxins in Puffer Fish cannot be destroyed by cooking or freezing, FDA restricts import of this product from any and all sources, worldwide. Shipper Products from various shippers may also be subject to DWPE by FDA due to factors such as contamination or adulteration. An example: Import Alert #16-105, DWPE of Seafood and Seafood Products from a specific manufacturer or Shipper due to Histamines. Manufacturer & Product Specific As with the case of Import Alert 99-32, FDA also retains the right to detain without physical examination specific products from a manufacturer. Other examples of this include: Import Alert 89-16, DWPE of Products from Medical Device Firms that refused FDA Inspection. Import Alert 99-37, DWPE of Low-acid Canned Foods and Acidified Foods that do not have Filed Scheduled Processes. FDA Inspections of Foreign Food Facilities FDA requires food facilities to respond to inspection requests within 24 hours and the Agency may interpret a lack of response as refusal of inspection. It’s also important to keep in mind that FDA communicates an inspection request with a facility’s U.S. Agent in charge. It’s prudent to designate a reliable Agent to avoid miscommunication or late responses. When preparing for an inspection, it is sound strategy to familiarize yourself with common FDA violations so you can assure the same mistakes aren’t made at your facilities. For customized preparation assistance, Registrar Corp can dispatch a Food Safety Specialist to your facility to conduct a Mock FDA Inspection. As part of this inspection service, our Specialist will help identify potential food safety issues in the structure, processes, procedures and documentation used in your daily production. What to Do When You’re on FDA Red List for Import Alert 99-32 To be removed from an Import Alert 99-32 and its red list, a facility is required to petition for FDA inspection. FDA states that it may be at least a year before FDA can return to inspect a facility that initially refused. Given this, full cooperation with FDA inspection is critical in avoiding loss of revenue from an otherwise avoidable Import Alert. To remove a brand’s product from the FDA Red List, information should be provided to the Agency to demonstrate that the firm has completed FDA inspection and meets the criteria for removal. The process requires you to provide sufficient evidence of your corrective actions. It may also require multiple compliant shipments to be reviewed by FDA’s Division of Import Operations. Registrar Corp has spent the last two decades helping over 30,000 companies each year across 175+ countries navigate the complexities of FDA compliance. We know how to help you submit the most complete and evidence-based petition for removal and keep your products out of detention. Discover how Registrar Corp helps keep your business off Import Alerts and avoid disruptions.

Food & Beverage

The FDA List of Allergens establishes a guidepost that helps the Administration regulate food and beverage companies in how — and what — ingredients are listed on their packages. When it comes to food, allergic reactions vary in severity from mild symptoms to more severe, life-threatening anaphylaxis. For this reason, with certain foods or substances that cause allergies or other allergic reactions, there are specific labeling requirements enforced by FDA that companies should be aware of. What Are FDA Food Allergens? According to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), a food allergen is an ingredient in any food or beverage that triggers a mild to severe immune system response in reaction to certain proteins that are present in the ingredient. Due to the prevalence, potential severity, and threat to public safety that these allergens represent, FDA has established guidance for the food industry and its consumers on how to identify and manage allergen hazards in both food and beverages. How Is the FDA List of Allergens Used? FDA updates and uses their allergen list to help conduct inspections and establish various labeling controls to prevent undeclared allergens during the manufacturing and packaging process of foods or ingredients. They will sample products to check that FDA Food Allergens are properly labeled on products and even determine if food facilities are implementing proper controls to prevent allergen cross-contact for items on the list. When food safety issues are identified in relation to the presence of a food allergen, FDA enforces product recalls and will immediately notify the public, or may even issue an Import Alert, seize and remove violative products from the marketplace, or simply refuse entry of imported products. The FDA List of Allergens: 9 Major Regulated Foods There are now 9 major FDA food allergens that together cause more than 90% of food allergies in the U.S. Each year, these foods cause about 30,000 consumers with food allergies to need emergency room care. Worse, 150 individuals die each year due to severe reactions from food allergens. It is for this reason FDA enforces any packaged food containing these allergens to declare the ingredients on its label to warn its consumers. Here is the current list of Major FDA Food Allergens: Crustaceans Crustacean shellfish consist of softshell seafoods that are non molluskan. They are aquatic animals that have jointed legs, a hard shell, and no backbone. Some foods in this group are: Lobster Shrimp Crab Crayfish Prawn Krill Fish Allergies to finned fish is more common in adults than children and affects roughly 1% of the world’s population. Some of the fish FDA closely monitors and regulates as allergens are: Haddock Cod Tilapia Tuna Salmon Perch Flounder Peanuts Despite its name, a peanut is actually a legume, not a nut. Although there are four main varieties of peanuts, all peanuts come from the same plant, Arachis Hypogaea. The most common variety is the Runner. This peanut makes up 80% of what is grown in the U.S. and is what most manufacturers use to create peanut butter and peanut confections. Tree Nuts Tree Nuts is a broad category that covers many foods that are used as ingredients and those that are not. FDA & the FALCPA considers the following foods as allergens under the Tree Nut category: Almonds Cashews Pecans Walnuts Macadamia Pistachio And many others Milk When it comes to Milk, most allergens arise out of the proteins Whey and Casein. Though most commonly associated with cow’s milk, allergic reactions can occur with other common milks such as goat, sheep, and buffalo. Unlike an intolerance that doesn’t involve the immune system, milk allergies are most common in children and can be as mild as nausea to severe and life-threatening as anaphylaxis. Eggs Chicken eggs are the most common cause of an egg allergy, the proteins found in the whites and yolk triggering a mild to severe reaction. However, other animal eggs, such as duck, turkey, or even quail, may cause a consumer’s immune system to overreact. Wheat When FDA talks about “wheat” they refer to any plant species of the genus Triticum. This genus includes the following grains: Spelt Kamut Triticale Semolina Einkorn Emmer Common Wheat Durum Wheat Sesame Sesame allergy is growing at a much faster rate in the U.S. than other food allergies and is estimated to be as common as fish allergies, soy, and even some tree nut allergies. Due to the rapid growth of sesame allergy, this seed is officially the ninth major food allergen recognized by FDA. Soybeans Like peanuts, soybeans are a legume that are used in a variety of common foods such as tofu, soy sauce and milk, natto, and miso. Allergic reactions to soy are generally mild and, although rare, severe and potentially life-threatening reactions do occur. Labeling Requirements for FDA Food Allergens The Administration requires that all food labels identify any source of major FDA food allergens that are used to make the food in the package. This requirement is considered met if the common name of an ingredient identifies that allergen's food source name. FDA also requires that the type of tree nut, the species of fish, and species of crustacean to be clearly named. There are two ways an allergen’s food source can be declared on the label: In parentheses following the name of the ingredient. Ex: flour (wheat), whey (milk), and lecithin (soy). Immediately after or next to the ingredient list in a clear and prominent contains statement. Ex: “Contains wheat, milk, and soy.” How to Assure Compliance With FDA Food Allergens Registrar Corp has spent 20 years assisting over 30,000 companies each year navigate the complexities of FDA compliance across 175+ countries. We know how to help you meet the stringent federal labeling requirements and prepare your products for the U.S. market. With our Label Review service, you have the ongoing support of a professional label compliance partner. Discover how quick and easy it is to gain and maintain compliance with FDA food allergen labeling requirements.   Frequently Asked Questions Does the FDA consider coconut an allergen? FDA recognizes coconut as a tree nut, and thus an allergen that must be declared. This can be confusing for some, as coconuts are technically considered to be fruits and there are few instances of people being allergic to both true tree nuts and palm coconuts. Does the FDA consider sesame an allergen? Yes. As of 2023, sesame is the ninth major FDA food allergen as recognized in the Food Allergy Safety, Treatment, Education, and Research (FASTER) Act, a federal law passed in 2021. How does the FDA differentiate between food sensitivities and food allergies? A food sensitivity or intolerance does not involve the immune system. A food allergy occurs when immune cells bind with certain proteins found in a particular food and trigger a mild to severe histamine response.

Medical Devices

Before marketing a Class I medical device — or even a Class II or III — in the United States, manufacturers should first gain a solid understanding of how the U.S. Food and Drug Administration (FDA) classifies each medical device. Simply put, FDA divides medical devices into classes to determine the regulations a device is subject to. They provide a blueprint for the path to legally marketing that device in the U.S. The Administration regulates all medical devices marketed in the U.S.. It assigns every single device a classification based on the possible threat it poses to the health and safety of a patient should something go wrong with it. FDA has classified over 1,700 unique types of medical devices. They are listed in the Code of Federal Regulations (CFR) under 16 specialties (also known as panels). Classifying a device according to one of the 16 panels is beginning of understanding whether you are manufacturing a Class I medical device, or a Class II or III. What Are FDA Medical Device Classifications? Medical device classifications indicate what controls apply to a device and what regulatory submission, if any, is needed to market the device. When a device is subject to certain controls and/or submission requirements, these requirements must be strictly adhered to. If a manufacturer markets a medical device without applying the applicable controls or obtaining approval for applicable regulatory submissions, FDA considers the device to be adulterated or misbranded and the device is subject to FDA’s enforcement actions. Class I Medical Devices Class I medical devices maintain little contact with a patient and have minimal impact on their overall health. Typically, these devices do not influence or interact with a patient's internal organs, circulatory, or central nervous systems. Almost half — 47% — of medical devices fall under Class I and roughly 95% of these are actually exempt from the regulatory process. If a medical device is considered exempt, a 510k premarket notification and premarket approval (PMA) is not required before marketing the device in the U.S. However, the manufacturer must register their establishment and their products with the FDA. They are also required to comply with the same FDA General Controls which apply to each Class of medical device which enforce adulteration, misbranding, device registration, records, and good manufacturing practices. Class I Medical Device Examples Examples of Class I Medical Devices include enema kits, stethoscopes, and latex gloves. Other examples include: Bandages Bedpans Tongue depressors Surgical masks Irrigating dental syringes Class II Medical Devices Class II medical devices present a higher amount of risk due to the fact that they are more likely to come into sustained contact with a patient. For this Class, general controls are not enough to provide adequate assurance of the safety and effectiveness of the device and FDA places additional Special Controls on them to help enforce proper safety. Special Controls depend on the individual device and may include unique labeling requirements or performance standards. These medical devices are considered Class II devices and comprise 43% of all medical devices in the U.S. market. Class II Medical Device Examples Examples of Class II devices include surgical gloves, contact lenses, and some pregnancy test kits. Other examples of these products include: Blood pressure cuffs Syringes Blood transfusion devices Powered wheelchairs Contact Lenses Class III Medical Devices Medical devices classified as Class III are those that pose a moderate to high threat to the patient's safety. They generally sustain or support life, are implanted into the patient, or present a potential of unreasonable risk of illness or injury. About 10% of medical devices are categorized as Class III and General and Special Controls are not enough to assure the safety of these devices. Products that fall in this category are subject to additional FDA measures like premarket approval. Class III Medical Device Examples Class III medical devices include products like implantable pacemakers and breast implants. Other examples include devices such as: Defibrillators High-frequency ventilators Cochlear implants Fetal blood sampling monitors Implanted prosthetics How to Determine What Your Medical Device Class Is FDA has categorized well over 1,700 unique types of medical devices. They have organized each in the electronic Code of Federal Regulations (eCFR) into groups known as 'specialties'. Identifying which of these specialties your medical device falls into is generally the first step in understanding whether you are manufacturing a Class I medical device, a Class II, or a Class III. The 16 Specialities, or “Panels,” listed in alphabetical order are: Anesthesiology Cardiovascular Chemistry Dental Ear, nose and throat Gastroenterology and urology General and plastic surgery General hospital Hematology Immunology Microbiology Neurology Obstetrical and gynecological Ophthalmic Orthopedic Pathology Physical medicine Radiology Toxicology Classifying your Medical Device typically begins by selecting your Specialty/Panel. By selecting your respective panel, you will be sent to an array of devices that fall into that category. For example , if you’re looking to identify the classification of a blood pressure cuff, you would select the Cardiovascular category followed by “Blood Pressure Cuff” under cardiovascular diagnostic devices. Once you click the Blood Pressure Cuff, you will be sent to the device information page. It is here under “Classification” that you can see that blood pressure cuffs are categorized as Class II medical devices for performance standards. Make Medical Device Compliance Quick & Easy Whether you're bringing a Class I Medical Device to market or a Class III, compliance can be tricky. From accurately identifying device classification to complying with a changing regulatory landscape, getting it right can be a time-consuming and complicated process. It doesn’t have to be. Registrar Corp has spent over 20 years helping more than 30,000 companies each year across 175+ countries navigate the complexities of FDA compliance. We know how to help you quickly bring your medical devices to market. Discover how simple Medical Device compliance can be.

ComplyHub™Food & BeverageFSVP

With approximately 32% of the fresh vegetables, 55% of the fresh fruit, and an overall 15% of the food consumed in the United States being imported from other countries, the Foreign Supplier Verification Program (FSVP) is one of the most important rules established under the Food and Drug Administration’s FSMA. The purpose of the Food Safety Modernization Act (FSMA) is the prevention of food safety hazards throughout the supply chain and to provide the FDA with the resources and authority to take actions necessary for protecting US consumers — regardless of where the food was produced. As part of that mission, the FSVP Rule mandates importers to assure all imported foods meet the same stringent food safety standards as those required for food products produced in the US. Jump to One of These Sections: What is the FSVP Rule Who is Subject to FSVP Compliance The FSVP Checklist for Success Top FSVP Violations in FY2023 FSVP Modified Requirements & FSVP Exemptions Required Documents for FSVP Compliance Is FSVP Certification Required? How to Simplify FSVP Compliance What is the FSVP Rule? FSVP stands for Foreign Supplier Verification Program. With this rule, the US Importer is defined as the entity and/or person responsible for the safety of the food that they are importing. Every importer subject to this rule must implement and maintain FSVPs in which they evaluated and approved each of their food and beverage suppliers. It also mandates that these Importers have conducted supplier verification activities to assure the food is both safe and in compliance with FDA food safety requirements, as applicable. An importer’s FSVP must make sure that: All food is produced in a manner that meets the same level of public health protection as with established preventive controls for human food or animal food, and/or the produce safety rule, as applicable Imported food is not considered adulterated as defined under section 402 (§342) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) Food products intended for human consumption are not misbranded concerning food allergen labeling as defined under section 403(w) of the FD&C Act Who is Subject to FSVP Compliance? Under the Foreign Supplier Verification Program, US importers are required to evaluate and approve suppliers and to conduct supplier verification activities. An importer is defined as the US owner or consignee of the food offered for import at time of entry. This is someone who either: Owns the food Has purchased the food Has agreed in writing to purchase the food at the time of US entry If there isn’t a US owner or consignee at time of entry, the foreign owner must designate a US agent or representative to fulfill FSVP responsibilities. This must be confirmed in a signed statement of consent. An FSVP importer must be located and conduct business in the United States meaning they must have personnel physically present in the United States. Essentially, if there is a written agreement, paid invoice, or a purchase order for food for a specific US entity at the time of US entry, then that US entity meets the definition of owner and is therefore responsible for and subject to FSVP. FDA is not looking at the intermediaries, but at the consignee, owner, or US Agent designated for FSVP purposes. The FSVP Checklist for Success FDA has made FSVP requirements quite clear and for each category of food you import, there must be a written FSVP for each supplier which must be developed and implemented by a Qualified Individual. The FSVP must detail all the necessary verification activities and documentation to demonstrate compliance for each of your suppliers. This includes the creation of documented processes for confirming the compliance of the foreign supplier, maintaining records, and conducting other essential tasks like taking corrective actions when issues are discovered. FSVP requirements are as follows: An FSVP importer must evaluate any food risk by checking each supplier’s food safety history and performing a hazard analysis by reviewing the process for any foreseeable hazards. An FSVP importer must verify each supplier by either an annual on-site audit of each supplier’s facility, sampling and testing, a review of food safety records, or the use of a third party to verify and provide proper documentation. Though the requirements seem straightforward enough, there can be many steps and considerations that can complicate FSVP compliance. We’ve put together a simple checklist of actionable steps that help take the complexity out of the process: 1. Designate your FSVP Qualified Individual The FSVP qualified individual (QI) is a person who has the education, training, or experience necessary to perform FSVP activities and can read and understand the language of records that they must review. It is important to know that in order to conduct supplier evaluations and FSVP activities, the QI must understand the FDA regulations applicable to the food. The QI is not required to be an employee of the importer. 2. Identify Suppliers and Food Products to Be Imported The first step to FSVP compliance is to have a complete list of the food products you import and who the foreign suppliers are for those products. You will also want to take note of which foods are subject to or are exempt from FSVP. This identification is essential for evaluating and approving the correct supplier, identifying the applicable FDA food safety regulations, conducting an adequate hazard analysis, and determining and performing proper verification activities to ensure food safety. What Is A Foreign Supplier Under FSVP? It's the entity that manufactures or processes the food, grows the food or raises the animal. In other words, it's the manufacturer or processor of the food — or the farm in the case of fresh agricultural commodities and live animals for use in food (outside of those regulated by USDA). Some examples FDA gives are boar, elk and bison. 3. Evaluate Supplier’s Compliance According to Regulations You must evaluate the foreign supplier’s FDA compliance history and their food safety practices to determine their adequacy and if corrective actions are needed for approval. This includes evaluating if the supplier has had any import refusals, import alerts, recalls, failed inspections or other FDA actions issued against them. You must also evaluate the food safety related procedures, processes, and practices. Reviewing their food safety plan, procedures for implementing controls measures, sanitation practices, third-party audit reports, etc. are examples of records you may review to reach compliance determinations. It is critical to take corrective actions when issues are discovered. 4. Determine Associated Hazards After evaluating the supplier’s compliance and food safety practices, it's important to assess the risks associated with the products. This encompasses the possible biological, chemical, and physical hazards that are likely to occur in the food, the ingredients, within the production environment, and the packaging. It also encompasses many other factors including everything from farming practices and environmental contaminants to the equipment used and natural disasters, etc. It also considers the supplier’s food safety history in determining the likelihood of a hazard. 5. Identify Your Verification Activities Based on the results of your compliance evaluations and the hazard analysis, you must then identify appropriate supplier verification activities and the frequency that you will conduct them in to assure that the hazards in the food have been controlled and your supplier maintains compliance. This can include, alone or in combination, conducting onsite audits, sampling and testing of the food, and reviewing food safety monitoring records. 6. Monitor & Reevaluate Suppliers Once your FSVP is in place for each foreign supplier, you must continue to monitor and reevaluate the supplier’s compliance over time. Maintaining regular communication with the supplier and closely following their compliance history is key. You’ll want to pay special attention to any import alerts, refusals, or detentions that may arise between them and yourself or other importers. When becoming aware of a compliance concern, you must evaluate if corrective actions are needed and act accordingly. 7. Update & Reassess Your FSVP As you continue to monitor and reevaluate each supplier you may become aware of new information such as changes in your supplier’s food safety plan, product formulation, processing steps, or food safety concerns. You must update and reassess the FSVP as necessary to ensure that your FSVP reflects the changes and the current state of your supplier/product to assure they remain compliant and your assessments and verification activities are still adequate. These changes can affect any and all parts of your FSVP. 8. Maintain all FSVP Documentation & Supplier Records Finally, to demonstrate your continued compliance during an FSVP inspection, it is necessary to maintain both accurate and complete records of all FSVP activities and other pertinent information. The FDA requires you to keep records readily available from the past 2 years. These documents may include supplier agreements, shipping documents, product labels, food safety plans, audit reports, laboratory test results, written assurances, and other documents that you reviewed to determine and verify your supplier’s compliance. All documents must be provided in English during an inspection. Top FSVP Violations in Fiscal Year 2023 Out of over 1700 inspections, 44.2% earned a 483 citation for failure to even develop an FSVP. According to the FDA Data Dashboard for Inspections, 930 FSVP importers were caught without the necessary requirements in place and received either voluntary or official actions indicated, a failure rate of 54%. FSVP Modified Requirements & FSVP Exemptions As with any other regulation, there are certain exemptions and modifications to be considered when determining if or how FSVP affects your business: FSVP Modified Requirements There are various scenarios for which FSVP modified requirements may apply. These may depend on the type of foods offered for import, the country in which the foreign supplier is located, the financial status of the importer and supplier, or even the food’s intended use. For example: If you import dietary supplements, your FSVP must evaluate compliance with Current Good Manufacturing Practices (CGMPs) for dietary supplements as outlined in 21 CFR 111; not the FSMA rules like Preventive Controls or Produce Safety. If you import food from a country under a food safety system recognition agreement (FSSRA) with FDA, you must document that the food is within the scope of the agreement, that it was was processed or grown in that country, and that the supplier is under the oversight of — and in good compliance standing with — that food safety system. If you import food for which hazards are controlled by a food processing facility in the United States, then written assurances for control of those hazards by that food processing facility can satisfy verification requirements. If you are a very small importer or your supplier is a small supplier, then your FSVP verification activities simply consist of obtaining written assurances from the supplier and other basic information. Very small businesses are defined by FDA as having an annual sales and market value of the food they imported, manufactured, processed, packed or held (for example, held for a fee) for the past 3 years — including their subsidiaries and affiliates — that equals an average of less than $1 million for human food, or in the case of animal food, less than $2.5 million. The list above is not all inclusive but gives an idea of different types of modified requirements that the food you import may be subject to. Some FSVP modified requirements make approval and verification simpler, while others may require a more detailed approach and evaluating other food safety regulations applicable to the food. FSVP Exemptions Exemptions under FSVP also apply due to existent regulations, other jurisdictions with oversight on the safety of those products, or due to its intended use or destination, for example: Juice & seafood are subject to FDA’s Hazard Analysis Critical Control Points (HACCP) Meat and poultry are under the purview of USDA regulations at import Alcoholic beverages remain under TTB jurisdiction Foods for research and evaluation purposes only Foods solely for individual use Foods imported for processing and overseas shipment Transshipped foods List of Possible Required Documents for FSVP Compliance Recordkeeping is the most crucial part for demonstrating FSVP compliance. If you do not document your activities and maintain proper records, FDA determines the activities did not happen. Here’s a general list of information that may be requested of you during an FDA inspection in the form of records: Business Details The FDA initiates their inspections with a questionnaire in which they ask general information about your business operations such as: Who the person in charge is Who your FSVP qualified individual for is The list of products you import Your top suppliers and top customers Your financial status and other information However, it is important to know that FDA started their investigation before they contacted you for the FSVP inspection and they already have certain information about your operation. Understanding the details of your operations and having basic information readily available, makes initial interactions smoother and lets FDA know how prepared and aware you are about the business you run. Supplier & Product List The FDA uses Customs’ data in identifying the suppliers and products they want to inspect so they already know who you import from and what you are importing. You do not want to be caught off guard when it comes to this list. You should know with certainty who your active suppliers from the past 2 years are. You will also want to identify who may have been listing you as an FSVP importer without your knowledge or for foods that you don’t import from them. Not knowing this information puts you at substantial risk of receiving citations for suppliers you didn’t even conduct business with. Or, it may reveal suppliers you didn’t know you had and should have had FSVPs for. Product Descriptions & Labels One of the first things you should request from your suppliers is the product descriptions or specifications and their corresponding labels. Keeping this information accurate will not only help you identify the foods you import, but it will also allow you to conduct initial assessments. These assessments include identifying whether FSVP applies to the food in question and which FSVP requirements might apply. You’ll be looking at which food safety regulations you need to verify such as Preventive Controls vs Produce Safety, dietary supplements, low acid canned foods, infant formula, and others. You will also be identifying ingredient related hazards such as unapproved colors and additives and undeclared allergens, and other details that will help you identify controls and verification activities. Purchasing, Shipment, & Receiving Records You are required to verify that the foods you import are from approved suppliers. Purchasing records such as agreements, invoices, and purchase orders indicate products requiring verification of shipment records. This is especially necessary when the food products are received at your facility, a third-party warehouse or another destination you’ve arranged delivery to. This information helps to ensure the imported food is from the supplier you approved and that it is the food you actually purchased. Written FSVP Procedures This includes written steps or SOPs for conducting the various FSVP-related activities such as supplier evaluations and approvals, verification activities, taking corrective actions, managing FDA inspections, listing the FSVP importer at entry, maintaining records, training, among other processes and assigning responsibility for those tasks to a qualified individual. Qualified Individual Qualifications All FSVP activities must be conducted by a qualified individual. The FDA may request the qualifications, evidence of education, training, or experience of personnel responsible for the different tasks required under FSVP. The qualifications required of an individual will vary according to the FSVP requirements that apply to the importer — Standard vs Modified — and the food safety regulations applicable to the food. Verification Activities Importers must perform verification activities to ensure a supplier is compliant at time of approval and that they maintain compliance over time. FSVP verification activities vary according to the requirements the importer and/or supplier and food are subject to. Modified requirements for small businesses require obtaining written assurances as a form of this verification. However, importers subject to the full requirements must conduct more complex activities. All verifications occur at an established frequency and this frequency depends on the individual requirement, the level of risk associated, the type of food or process, how much you import from that supplier, and other factors. These activities also encompass the review of sampling and testing results, food safety records, and onsite audits. When issues are found you must verify that the supplier took corrective actions to resolve those issues. You must then keep evidence that these verification activities were conducted and maintain all the records you reviewed. Reanalysis & FSVP Updates This pertains to all records associated with the revisions made to an FSVP and maintaining the different versions that have been developed over time. Changes to the products imported, supplier food safety procedures, labels, or a supplier’s compliance standing may require a reanalysis of the FSVP. Any modifications made to the FSVP procedures, the FSVP for a supplier such as hazard analysis, verification activities, etc. must be documented and previous versions kept on file for no less than 2 years. Foreign Supplier Compliance Evaluations The evaluations and determinations on foreign supplier compliance must be documented. As the FSVP importer, you must check whether the supplier had warning letters, refusals at the port of entry, import alerts, or other actions regarding food safety violations and determine if corrective actions are needed. This evaluation includes reviewing their general food safety procedures and may even include review of third-party audit reports and/or FDA Inspection reports. You will also need to review the qualifications of the person in charge of food safety or quality control to ensure they are qualified. Some suppliers are hesitant to share their food safety practices, however, you cannot demonstrate compliance without reviewing their procedures, corrective action measures, and their food safety history. Hazard Analysis & Entities Controlling the Hazards If applicable, you must have a written hazard analysis, including the determination of potential food safety hazards and the evaluation of their likelihood and severity. Based on your determinations, you then compare your evaluation with your supplier’s food safety plan or procedures to ensure they’ve addressed the hazards and have appropriate controls in place. You must also identify any hazards that may not be controlled by your supplier and identify the entity responsible for controlling the hazard. A written hazard analysis does not apply an FSVP for dietary supplements. Is FSVP Certification Required? A quick search online will populate thousands of results that speak to FSVP certification courses. These certification courses cover the necessary information for individuals looking to learn how to develop an FSVP on their own. Certification, however, is not required to develop and implement FSVPs for each of your foreign suppliers as you only need a Qualified Individual on staff — or an out-sourced professional — to perform the necessary tasks and to establish each of the components for the FSVP. How to Simplify FSVP Compliance With so much of the US food supply imported from foreign sources, FDA requires exhaustive compliance and verification activities from FSVP importers. Attempting to evaluate your foreign suppliers and the foods you import on your own is certainly an option, though if you’re unfamiliar with the FSVP landscape and the numerous food safety requirements that may apply to the foods you import, it can be a lengthy and difficult endeavor that can eat away at resources better spent elsewhere. You can easily achieve full FSVP compliance by leveraging the world’s largest FDA compliance company in the industry. Registrar Corp has spent the last two decades helping over 30,000 companies each year across 180+ countries navigate the complexities of FDA regulations. We can help you, too. Discover how you can easily manage FSVP compliance 24/7 with Registrar Corp’s industry leading FSVP solutions.


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