If you are shipping or importing food into the United States, FDA may require prior notice. This information helps them assess whether the imported product meets safety requirements established in 21 CFR 1.276(b)(5).
When submitting food through the FDA PNSI system, you must provide certain information. This includes entering the name and contact details for the Manufacturer, Grower/Consolidator, Shipper, Owner, Ultimate Consignee and Holding Facility.
Product Information
As a manufacturer or exporter, you must submit Prior Notice for each product that is imported or offered for import. Additionally, include information about growers (if known) in the Prior Notice if they have consolidated the items into one shipment.
The FDA PNSI and CBP’s ABI/ACE systems offer feedback to help minimize errors in Prior Notice information. For instance, if you enter the incorrect grower name or location by mistake, the system will notify you and give you an opportunity to make corrections electronically.
You may save Prior Notices as a draft before submitting them. Doing so allows for changes to the draft before submission, which could be especially useful if entering information in another language or using a computer with another operating system than what you currently use to log into the system.
Production Identifiers
Under the FDA’s Unique Device Identifier (UDI) rule, device labelers must include a UDI on device labels and packages unless an exception or alternative is provided by the rule. A UDI must be provided in plain text as well as using automatic identification and data capture (AIDC) technology such as barcoding for tracking purposes.
If a device is intended for multiple uses and must be reprocessed before each usage, its labeler must also mark its Unique Device Identifier (UDI) directly onto the device. Furthermore, device labels must submit information concerning UDI to a new Global Unique Device Identification Database (GUDID).
Vision28 offers a range of software solutions to assist you with meeting the UDI requirements set out in the us fda prior notice rule. Talk to one of our representatives today to discover how a custom solution can simplify the UDI process and reduce compliance costs. Your dedicated representative will be glad to answer all your questions and offer a free consultation.
Related Facilities
The FDA requires advance notification for shipments of food and feed products – including food for animals – imported to the United States. Submitting this data before they arrive helps improve risk assessment and inspection processes as well as enable CBP officers to detect contaminated foods before they enter the country.
To add related facilities to your prior notice, log into the Prior Notice System Interface website and select the Related Facilities tab. After selecting an appropriate facility, the screen validates your information and displays it on the Prior Notice: Related Facilities (View) page.
The Prior Notice: Related Facilities (View) page displays the product’s manufacturer, owner and shipper along with their complete growing location address details. You may also add an Ultimate Consignee or Holding Facility here if needed. Utilizing this tab is highly recommended since it provides easy access to this data at any time; particularly helpful if entering data for multiple related facilities simultaneously.
Refusal or Hold
When FDA reviews an imported shipment, they can determine that a particular product may have violated the law. If this is the case, they will detain the shipment and issue a Notice of FDA Action – Detention (a detention notice) to the importer, owner, consignee and customs broker.
When you receive a detention notice, it is essential that you respond before the deadline indicated on the notice and provide all pertinent testimony. Failure to do so could result in FDA refusing admission of your shipment.
Prior Notice is required for all shipments crossing the border by air, sea and road. This notification can be submitted through either the Automated Broker Interface (ABI) or FDA’s PNSI, both free of charge. Unfortunately, this process can take a lot of time and be challenging for many high-volume traders due to its time-consuming nature.
