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Are you a non-US manufacturer of Pharmaceutical Products & Medical Devices, or Foods & Food Products? Let Wellkang LLC be your reliable US Agent registered with the FDA - U.S. Food and Drug Administration! About Foods & Food Products:
About Pharmaceutical Products & Medical Devices:
 Why choose Wellkang LLC? Wellkang LLC is a member company of the Wellkang Group of Companies- a world leading consultancy group in FDA affairs incl. 510(k) PMN submission, UL, CCC Mark, and CE Marking. Wellkang help worldwide exporters to gain global market access. Wellkang have offices in the USA (Melbourne/FL, Wilmington/DE), Europe (London, Stockholm) and Asia (Hong Kong, Shenzhen, and Xi'an). How can Wellkang help you? Wellkang LLC is offering a full range of services for non-US manufacturers, of Pharmaceutical Products & Medical Devices or Foods & Food Products, needing assistance with the FDA registration process. Wellkang LLC can help you:
What happens to my products if I don't register? If you are a foreign facility, you may 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. Is that an offense if I don't register? Failure to register is a prohibited act, FDA may bring a civil action or a criminal prosecution against the offender. Is Wellkang LLC part of the U.S. government? No. Wellkang LLC is a private company. It is not affiliated with any agency of the United States government. About Foods & Food Products: Who must register? 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.” Food is defined broadly to include all foods regulated by FDA, including raw agricultural commodities, pet food, alcoholic beverages, food ingredients, dietary supplements and dietary ingredients, and substances that migrate to food from immediate food packaging and other articles that contact food. Do foreign facilities have to register? Since December 12, 2003, ALL food facilities (both domestic and foreign) MUST be registered with the FDA unless exempt. A foreign facility is any facility not located in one of the 50 States of the United States, Washington, DC, Puerto Rico, or a U.S. Territory. Do foreign facilities must have a U.S. Agent? 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 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. Is my facility exempt from registration? Certain types of facilities are exempt from registration. You may be exempt if you operate a:
What if information in my registration changes? If any registration information changes, you must submit an update to FDA within 30 calendar days after the change. How will registration work? Wellkang LLC will submit registration to FDA on your behalf and obtain a confirmation and registration number for each of your facilities. To find how easy it is to use Wellkang's service, please click here. What is FDA'S new Food Bioterrorism Regulation? This answer is only available to our existing customers, if you are already our customer, please click here to log in. What are FDA'S new food shipping regulations This answer is only available to our existing customers, if you are already our customer, please click here to log in. About Pharmaceutical Products & Medical Devices: Who must register? Do foreign facilities have to register? Since February 11, 2002, ALL Foreign Establishments whose products (Human Drugs, Animal Drugs, Biological Products, and Devices) are imported or offered for import into the United States MUST be REGISTERED with the FDA.
Do foreign facilities must have a U.S. Agent? ALL Foreign Establishments must designated a United States Agent, i.e. a US Agent. The U.S. agent plays the role of the domestic representative for the foreign facility through which all communication with the FDA takes place. What if information in my registration changes? If any registration information changes, you must submit an update to FDA within certain period of time. How will registration work? Wellkang LLC will submit registration to FDA on your behalf and obtain a confirmation and registration number for you. To find how easy it is to use Wellkang's service, please click here. How to contact Wellkang? Anything unclear yet? Our Wellkang team, a world leading regulatory consultancy, are here ready to help you!
Or, at the following address-
P.O. Box 360307 681 Saint Clair St. Melbourne, FL 32936-0307 USA Tel: +1(321)574-0461 Fax: +1(321)821-1340 Wellkang® Group is your one-stop global solution provider! Sell to US? Here are your solutions: www.FDA-Registration.com www.FDAagent.us www.510k.org Sell to Europa? Here are your solutions: www.CE-marking.com www.Auth-Rep.com Sell to China? Here are your solutions: www.CCC-mark.com www.CCC-mark.cn |
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