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FDA (Food & Drug Administration) in the USA
- BIOTERRORISM COMPLIANCE REGULATIONS FOR
ALL EXPORTS OF FOOD &/OR BEVERAGE FOR BOTH HUMANS &/OR ANIMALS TO THE
USA. DO YOU, OR YOUR CUSTOMERS, EXPORT YOUR PRODUCT(S) TO THE USA ? Since the terrorist attacks in the US, on September 11th, 2001, the US FDA have been worked on and completed new regulations to protect public heath and the US economic interest. Every Facility within this "Loop" from the farm gate to arrival in the USA MUST be registered with the FDA, in regard to Bioterrorism Compliance Regulations. The only exemption to this rule are Meat, Poultry & Egg Products as they are already subject to USDA (United States Department of Agriculture), regulations. IF YOU ARE NOT REGISTERED WITH THE FDA IN THE USA your products will not be allowed to land and pass US Customs. There was a time of lenience BUT this is now over, the FDA has tightened completely their control in regard to both Registration and Prior Notices. PRIOR NOTICES ARE REQUIRED for each product within each shipment and must be electronically submitted no sooner than five days before the shipment arrives in the USA but no later than 8 hours prior to arrival if the goods are being sent by sea and 4 hours if the goods are being air freighted. The SUBMITTER OF PRIOR NOTICES can be either the exporter, the shipping agent of the importer/agent. Thirdly, exporters must keep detailed records of their manufacturing, transportation and packaging processes and ensure that the companies they are dealing with (in their loop) are also registered with the FDA where appropriate. Businesses are also required to give details of an agreed US Agent for the FDA Bioterrorism Compliance Regulations as they Register,. This must be someone who resides in the US or has a place of business in the US. Kiwi & Associates fills that role and offers the services of US Agent for Bioterrorism Communications Regulations only. The annual cost is $220.00 plus gst plus a $20.00 Insurance fee. For further information - contact: robyn@kiwiandassoicates.com HOW TO CREATE AN ACCOUNT AND REGISTER WITH THE FDA. This is done online, on the FDA Interface - www.fda.gov Before you begin, please contact our office robyn@kiwiandassociates.com of phone (07)376-5109 or 0274-908-644 We will then email you all the relevant details and discuss your requirements.
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