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Food & Beverages

Food Facilities Must Register with FDA

The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (the Bioterrorism Act) requires all non-U.S. facilities that manufacture, process, pack, or hold food for human or animal consumption in the United States to register with the FDA..

FDA Registration has to be carried out according to the specific FDA instructions. Contact ‘De System’ today and receive your FDA Facility Registration Number without further delay!

The Bioterrorism Act defines foreign facilities 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. Often exporters need to register multiple facilities where food is stored, packed and prepared for shipment

De System’ is a full-service provider that will quickly and professionally register your facility and/or serve as your U.S. Agent Registration Representative. Upon special request, ‘De System’ can also assist in the preparation of Prior Notices for shipments coming into the USA.

De System is a leading authority on United States Food and Drug Administration (FDA) compliance for the worldwide food industry. Under the supervision of an experienced attorney, we provide quality, personal service to small, medium & large sized food and beverage exporters shipping food into the US.

There are proposed new requirements and authorities applicable to foods, including establishment of a food safety plan, safety standards for fresh produce, periodic inspections, and certification of facilities and accreditation of laboratories, and mandatory notification and recall, among others. FDAGA 2009 retains these and adds others, including:

  • All facilities would be required to develop and implement a HACCP plan (conduct a hazard analysis, implement preventive controls, monitor effectiveness of those controls, and keep records).
  • FDA’s access to records would be significantly strengthened, perhaps finally putting to rest the decades-long debate over the extent of FDA’s authority to access records during a food inspection. In addition, farms and restaurants would be subject to recordkeeping requirements.
  • FDA’s administrative detention authority would be significantly strengthened.
  • Some of the violations that were previously categorized as “prohibited acts” (e.g., failure to register or pay fees) would now render a food misbranded.
  • Making false statements to a facility or laboratory certifying agent would be a prohibited act.
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