If you only invoice from your location and items shipped directly to the destination by the original manufacturer, then your facility need NOT to be registered with the FDA.
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USA Food Regulatory Agency of the Department of Health and Human Services has taken steps to protect the public from the food supply and related emergencies by enforcing the Bioterrorism Act from December 12, 2003.
• Must submit establishment registration information, with consent to inspect the facility at any time as per the FDA protocol
• Must renew food facility registrations every other year, with consent to suspend registration if found reasonable cause as per the protocol
• Each food facility should have its own 11-digit registration number. If the same management has multiple facilities for manufacture and export to the USA, each of the facilities is required to register and obtain different food facility 11-digit registration numbers
• FDA Food Facility registration is simple, but it is tiring and confusing for those doing it for the first time.
The extent of Documented Information differs as per:
• All foreign facilities engaged in the manufacturing, Repacking, Relabeling & Warehousing of food items used for consumption in United States must appoint US Agent.
• All foreign Food facilities planning to register with FDA must furnish the Data Universal Numbering System (DUNS).
• It is mandatory to submit online application and appoint US Agent before proceeding with FDA application.
• We, the regulatory experts / US Agent will apply for Registration on all working days.
• On receipt of application FDA will generally issue number soon. The registration number will be forwarded to registered mail ID only.
• US Agent will issue registration Certificate as a proof to show potential customers and shipping companies. Food facility registration details are kept confidential by FDA.
• It takes 2 weeks to done process
• Support for Renewal before 31st December every year.
If you only invoice from your location and items shipped directly to the destination by the original manufacturer, then your facility need NOT to be registered with the FDA.
Food and Drug Administration never approve or disapprove any US Agent organization.
Yes, the manufacturer registration is a must! In case of any food quality issues, the FDA will conduct an ONSITE audit as per 21 CFR 110 or 21 CFR 111.
If the exporter stores food at the facility, the same facility also must register with FDA. If you just invoice and the manufacturer sends it to the destination, your facility need NOT register.
NO. The FDA Food Facility Registration number is confidential. You need to mention it only at the time of sending a prior notice.