U.S. Agent Program for Foreign Food Facilities
ALL FOREIGN FOOD FACILITIES MUST BE REGISTERED WITH THE FDA AND
DESIGNATED A U.S. AGENT BY DECEMBER 12, 2003
WHY ARE U.S. AGENTS REQUIRED?
In response to the acts on September 11, 2001, the U.S. Congress
passed the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002, which President Bush signed into law June 12,
2002. Title III of this Act discusses the safety of the Food and Drug
Supply to the U.S., of which the U.S. FDA is responsible for carrying
out Subtitle A (Protection of the Food Supply) and Subtitle B
(Protection of the Drug Supply). Given its responsibility, the FDA has
proposed regulation that all food facilities (both domestic and foreign)
be registered with the FDA by December 12, 2003. Domestic facilities
that are not registered by this date may be subject to both civil and
criminal penalties. Any foreign facilities not registered will have
their goods held at the U.S. port of entry or moved to an FDA secure
location.
The regulation also states that all foreign food facilities must
include the name of a U.S. agent with their registration. 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 IS THE DEFINITION OF A FOREIGN FACILITY?
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 for consumption in the
United States.”
This may mean that within your company, you may have only 1 foreign
food facility or multiple foreign food facilities. If your company
manages multiple geographically dispersed facilities, then you must
register each facility. If there are multiple management teams that
manage operations within one building, each of the management teams will
need to be registered as an independent facility. If you are unsure,
please contact us to clarify how many facilities to register.
AS YOUR U.S. AGENT, WHAT WILL mdi DO?
Based on the responsibilities outlined by the U.S. FDA, a U.S. Agent
is responsible for the following activities:
- Keep a physical office in the USA
- Provide updates of the Foreign Firms establishment registration
and product categories
- Provide communications between the FDA and the Company, e.g.
terrorism threats
In addition to the responsibilities of the U.S. Agent, the foreign
facility has the following responsibilities:
- Provide mdi an update of changes to the Establishment registration
(e.g. address, change in ownership)
- Notify mdi of any new products or changes to already listed
products (e.g. dropping them from the product line)
- Notify mdi of changes in telephone numbers, fax numbers or email
addresses.
WHAT IS mdi’s U.S. AGENT PROGRAM?
In addition to the required responsibilities of a U.S. Agent
described above, mdi provides its clients the following additional
services:
- Updated newsletters or information on US regulations that might
effect the foreign manufacturer
- Discounted rates on other mdi services (e.g. FDA audits, GMP
training HACCP)
WHAT IS THE COST OF mdi’s U.S. AGENT PROGRAM?
Our prices are very competitive. Please contact us for a specific
quote.
HOW DO YOU SIGN UP FOR mdi’s U.S. AGENT PROGRAM?
Please go to our sign up page to sign up for mdi’s U.S. Agent
Program. If you have specific questions you can call us at +1 (516)
482-9001 (ask for Diane Furnari or Alan Schwartz) or e-mail us at
info@mdiconsultants.com.
Click here for the Sign-up Page.
FAQs
1. Who is mdi Consultants?
mdi Consultants, Inc. is the leading quality assurance, regulatory
compliance and clinical consulting firm that assists healthcare
companies with market entry into the United States and Europe. mdi has
been in business since 1978 and provides FDA compliance, ISO compliance,
Crisis Intervention and CE Mark services to the medical device,
pharmaceutical and food industries. We have an international staff of
former industry executives, FDA officials and quality managers that
provide expert knowledge to our clients. mdi has served over 500
companies worldwide on their important quality and regulatory issues. In
addition mdi has been serving as U.S. Agent for medical device and
pharmaceutical companies since 1990. We have also been serving as
European Authorized Representative since 1999.
2. What happens if I don’t register?
If you don’t register by December 12, 2003, then the U.S. FDA has the
right to hold all your shipments at the U.S. port of entry. If held by
the FDA, they may require you to register before letting the shipments
enter the country, which could result in a significant loss of time and
revenue for you.
3. Once registered, how often do I need to update my information?
You need to update your information only when changes to the
information occur. If you change your parent company, the location of
your facility, your phone number, your emergency contact information,
then you must immediately contact mdi, so that we can update your
information with the FDA. The FDA provides you a 30 day window in which
to update your information.
4. Is registration information open to the public?
No, all information is held confidential. This information does not
fall under 5 U.S.C. 552 (the Freedom of Information Act)
