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FDA PREDICT: Determining Shipments to Examine at U.S. Entry

On May 14, 2015, the U.S. Food and Drug Administration (FDA) hosted a webinar on the process of importing products to the United States.  During the webinar, FDA discussed its system for determining which shipments to examine or sample before allowing them to enter the U.S., as well as best practices and common mistakes made when handling a detention.

Millions of dollars’ worth of FDA-regulated products are exported to the U.S. each day, and FDA cannot examine each and every shipment.  FDA uses a Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting (PREDICT) system to determine which imports to examine or sample upon arrival to the United States.  PREDICT utilizes data mining, pattern discovery, and open-source intelligence to assess the relative risk of FDA-regulated products.  It allows FDA to release low risk and consistently compliant products more quickly and to prioritize higher risk shipments for examination and sampling.  In other words, the lower the risk of a product and the better a company’s FDA compliance history, the lower the chance a shipment will get selected for examination and stopped at its port of U.S. entry.

While most shipments are chosen by PREDICT due to a risk-based assessment, the system also uses randomization for an additional level of security.  Therefore, even a low-risk or consistently compliant shipment could potentially be stopped for examination or sampling.

Once a shipment is examined or sampled, the Compliance Officer will classify the shipment as one of three things:

  1. Class 1 – Product will be released
  2. Class 2 – Results were inconclusive and the shipment will undergo further review
  3. Class 3 – Product will be detained

If a product is detained and is verified to be in violation of a U.S. law or regulation, the product may be refused. FDA Import Refusals are logged in OASIS, a publically-available database.  In some cases where FDA notices a pattern of non-compliance, a company may even be placed on an FDA Import Alert for a certain product.  If a company is on an FDA Import Alert, any shipments of that particular product will be subject to detention without physical examination (DWPE) upon arrival to the United States.

During the webinar, FDA offered some tips for handling an FDA examination or detention.  Tips included:

  • Submit the proper manufacturer information and address
  • Submit correct Affirmation of Compliance and hire an experienced Customs Broker.
  • Study Import Alerts and product requirements, and use a consultant if you’re unsure about anything
  • Cooperate with FDA Investigators and submit the information they need as soon as possible
  • Wait a couple of days after submission before calling a Compliance Officer, and know your Entry Number (a.k.a., Case Number) when you do
  • Use email and a follow-up phone call for lengthy discussions
  • Have goods available for FDA appointments
  • Be honest with the Compliance Officer about any errors made
  • Have all records and documents ready to show if the product is registered and keep all lab analysis results
  • Do not release goods until you receive the FDA Notice of “May Proceed”
  • Cooperate and comply with time frames and directions from the Compliance Officer

Common mistakes that FDA mentioned included:

  • Providing late or incorrect information
  • Calling or emailing many FDA offices or staff about one situation
  • Falsifying documents
  • Ignoring FDA Notices of Actions or Customs and Border Protection Summons and Penalty Notices
  • Demanding  FDA to release shipments or rescind a refusal

There are many things that can alter a company’s PREDICT score and increase the chance of a shipment being stopped: an invalid registration number, a product or listing number that doesn’t match up with a product code, labeling errors, data from a past FDA facility inspection, a consumer complaint, and others. That’s why it’s important to ensure you understand FDA regulations for your product and are in compliance before shipping to the United States.  Registrar Corp helps companies comply with U.S. FDA regulations.  We can ensure your company is properly registered with FDA, review your product labels for FDA compliance, and more.  Registrar Corp also offers an FDA Compliance Monitor that allows users to monitor FDA compliance issues that may be affecting their PREDICT score.

To learn more about Registrar Corp’s available services, visit www.registrarcorp.com, contact +1-757-224-0177, or chat with a Regulatory Advisor 24 hours a day at www.registrarcorp.com/livehelp.