Agde Corporation
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LETTER OF NOTICE
© Copyright 2003
Dear Facility Owners/Operators and Agents-in-Charge:
As of October 2003 all facilities that manufacture, produce, process, pack, hold or handle food, drug (pharmaceutical), biologic, and medical device, must register with the U.S. Food and Drug Administration (FDA). This new Facility Registration Regulation is necessary to carry out the four major safety provisions of the “Public Health and Bio-terrorism Preparedness and Response Act" passed by the U.S. Congress and signed into law on June 12, 2002. The Act is intended to assure public safety.
Final regulations have been prepared and was issued by the Secretary, through the FDA, for the following Four New Provisions: (1) “Registration of food Facilities with FDA”, that is owned and /or operated or having an agent-in-charge. Foreign and domestic facilities must designate a U.S. Registered Food Agent, by December 16, 2003, to handle the facility Registration and to serve as a point-of-contact for communicating both routine and emergency information between FDA and the registered facility(s). The agent must be available to FDA on a twenty-four hour/seven days a week (24/7) basis to ensure proper compliance with the Act in the event of an emergency.
Also effective December 16, 2003, FDA and U.S. Customs will require that U.S. bound imports from registered foreign facilities must provide (2) “Prior Notice of all imported food shipments” to the United States regardless of weather the product will be consumed in the United States. If prior notice is not given or is inadequate, the Act requires that imports be held until adequate notice has been provided. The Act has two additional requirements (3) “Establishment and Maintenance of Record Keeping”: for all foreign and domestic registered facilities and (4) “Administrative Detention”: FDA requires Administrative Detention if facility registration requirements are not in compliance with the "Public Health and Bio-terrorism Preparedness and Response Act."
In order to eliminate the potential burden on affected companies, AGDE, Corp., provides a service whereby interested companies may register and receive relevant regulation information as well as assistance in fulfilling the four FDA provisions. AGDE, Corp., can eliminate this burden for you and your company. If you would like to know more about FDA's new regulations you are invited to register with American Global Data Exchange Corporation (AGDE, Corp.), and join our services (If you decide to register for AGDE, Corp., services a copy of our Agreement with Annual U.S. Registered Agent Service “Fee Schedule” will be provided for you to review, sign and return with Annual Fee Payment(s)).
AGDE, Corp., can serve as your U.S. Agent and can handle all aspects of FDA’s registration process for your facility(s). As your agent we will send you updates and alerts as we get closer to the December 16th deadline and help you meet your obligations for prior notice and record keeping under the Act and much more. The AGDE, Corp. staff consist of expert consultants having many years of trade and compliance experience with FDA, and other associated Agencies.
If you would like to receive more information on AGDE’s Corp. services, complete the attached Pre-registration form and return it via: AGDE, Corp. Website: www.agdecorp.com, for online registration; E-mail: [email protected];
Fax: 866/455-9481, or by Airmail. AGDE, Corp. will confirm receipt of your request for pre-registration and begin application process for final registration processing. Upon release of final rule for FDA’s new regulations, scheduled for this October 10th, 2003. AGDE, Corp. will also provide you with timely updates and alerts as FDA approach the expected release date.
Visit our Web Site at www.agdecorp.com for more information on obtaining AGDE, Corp. services. We may also be contacted by Voice: 1+ (866) 899-4310; Fax: 1+ (866) 455-9481; E-mail: [email protected], or by Airmail at the above address. (As our registered client additional information and updates on the FDA new regulations is available thru AGDE, Corp.’s Web Site, Newsletter or by your written request).
Food Agents
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| Deals in (Products) :
Food Agents
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| Contact Information |
| Company Name : |
Agde Corporation |
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| Address : |
The Grand, 5801 Nicholson Lane, Suite #1424 |
| City : |
North Bethesda |
| Pin : |
20852 |
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| Country : |
United States |
| Telephone : |
866-899-4310 |
| Fax : |
866-455-9481 |
| Update on : |
8/7/2022 |
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