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.
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)