HYKKON group focuses on assisting US FDA-regulated facilities located outside the United States comply with FDA regulations governing their facilities and food, cosmetic and medical device products. We have multiple consultants on staff with significant legal training advising such industry clients.
HYKKON GLOBAL is in the business of assisting food facilities that sell or distribute food into the United States; we focus on providing that service. We can assist you with the following: serve as your “U.S. Agent” as required by FDA register your foreign facility under the new biennial registration requirements of the Food Safety Modernization Act; update or amend your registration materials when required; cancel your registration with the FDA in the event your facility closes or ceases exports into the United States; certify to your customers that your facility is registered with FDA (if you request this service provide you with information on pending FDA regulations and other valuable U.S. food industry trends or news.
If your facility is located outside the United States, and you don’t register in accordance with the Food Safety Modernization Act, you will not be able to import your products into the United States. Products from all foreign facilities that are required to register but fail to do so will be refused admission and held at the U.S. port of entry or moved to an FDA secure location.
Failure to register is a prohibited act under the U.S. federal Food, Drug & Cosmetic Act, and the FDA may bring a civil action or a criminal prosecution against violators.
No. We are a private company located in the United States offering “U.S. Agent” appointment and facility registration services. We are not affiliated with the FDA or the United States government.
The FDA has defined a facility as “any establishment, structure, or structures under one management at one general physical location, or in the case of a mobile facility, traveling to multiple locations that manufactures/processes, packs or holds food intended for human or animal consumption in the United States.” If you are such a facility, NO MATTER WHERE YOU ARE LOCATED, you must register with FDA unless you qualify for an exemption. If you are unsure about whether or not you need to register, please contact us at email@example.com to clarify how many facilities to register.
“Food” is defined broadly to include all foods regulated by FDA, including raw agricultural commodities (fruit, vegetables, and nuts), pet food, animal feed, certain alcoholic beverages, food ingredients, and dietary supplements, as well as certain substances that migrate to food from immediate food packaging and other articles that contact food.
Since December, 2003, ALL food facilities (both domestic and foreign) that manufacture, process, pack or hold food intended for consumption in the United States MUST be registered with the FDA unless exempt.
If you are a foreign facility that is required to register with FDA, you MUST designate a U.S. Agent. A U.S. Agent is defined as a person or entity residing or maintaining a place of business in the United States whom a foreign facility designates as its agent. The purpose of the U.S. Agent is to serve as a communications link between you and FDA; in addition, the FDA can look to the U.S. Agent for the payment of certain fees.
Cosmetic establishments are facilities where cosmetics are manufactured and/or packaged. Owners or operators of cosmetic manufacturing or packing facilities may voluntarily register their establishments, using a separate Form FDA 2511 for each facility location. Firms can register their establishments before or after their products are entered into commercial distribution and for sale to U.S. consumers. FDA assigns a registration number to each establishment location. A cosmetic manufacturer, packer, or distributor may also voluntarily file a statement for each product the firm has entered into commercial distribution in the United States. FDA assigns a Cosmetic Product Ingredient Statement Number (CPIS NO.) to each formulation filed in the Voluntary Cosmetic Registration Program. CPIS numbers do not have expiration dates, so it is important to follow the procedures in 21 CFR 720.6 to amend a filed formulation or to discontinue a filed product that is no longer in commercial distribution
If any registration information changes, we can assist you with submitting an update to FDA, which must be filed within 30 calendar days after the change.
You fill out the form/questionnaire here, pay the appropriate service charges, and USAgentServices.com will complete the registration materials, submit those materials to the FDA on your behalf, obtain a confirmation and registration number for each of your facilities, and relay that information on to you. We’ll also store that information for you in the event you need it at any time. We have made this process SAFE, SIMPLE AND COST-EFFECTIVE