FDA’s new Public Health Security and Bioterrorism
Preparedness and Response Act of 2002 significantly impacts your
company’s domestic and international supply chain. Effective
December 12, 2003, all FDA regulated products will be required to
comply with the new Bioterrorism Regulation, which mandates that all
foreign and domestic facilities that manufacture, process, pack,
distribute, receive or hold food for consumption by humans or
animals in the United States register with the FDA no later than
December 12, 2003.The second essential element of the
Bioterrorism Act requires an importer to transmit Prior Notice to
the FDA for food imported into the US within specified and strictly
enforced periods of time. FDA will use this information in advance
of arrival to review, evaluate and assess the shipment particulars,
then determine whether to inspect the imported food or to deny entry
of the cargo.
The Food and Drug Administration maintains a website document
outlining the latest
Questions and Answers Regarding Registration of Food Facilities.
Samuel Shapiro & Company, Inc. offers a new Bioterrorism
Registration Service on behalf of domestic or foreign facilities
required to register with the FDA under the scope of the
Bioterrorism Act. Shapiro can reduce your headaches by registering
your domestic and / or foreign facilities for you. We also offer to
act as a communications liaison between the FDA and foreign
facilities by availing ourselves as the U.S. Agent in charge. Both
of our new services, the Bioterrorism Registration Service and the
Bioterrorism Communications Liaison Service (U.S. Agent), are
available at very competitive rates.
Please contact our Consulting Team at
consulting@shapiro.com or
for more information on our FDA Bioterrorism Services.
