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Ensure Imports are Not Detained Due to FDA Non-Compliance

Jan 7, 2021 | Drug & Biologic Product Submissions, Life Sciences, Pharmaceutical and Cosmetics

In the final webinar of 2020, Reed Tech invited an expert attorney to discuss import compliance and how it ties into FDA compliance. David Wilson, Reed Tech, and Jennifer Diaz, Esq., Diaz Trade Law, discussed many topics ranging from compliant importation and FDA submissions to being prepared and audit ready in 2021. Below find a brief recap of our webinar with key highlights including our biggest takeaway: FDA non-compliance can often lead to drugs being detained by Customs.

Our guest speaker, Jennifer Diaz, is a Chamber’s ranked, Board Certified International Attorney, as well as the President and founder of Diaz Trade Law and Diaz Trade Consulting, specializing in Customs and International trade law and consulting services. Jen is an expert in matters concerning U.S. Customs and Border Protection (CBP) and the U.S. Food and Drug Administration (FDA). She shared her top 10 tips to ensure compliant importation with our webinar audience.

  1. Know your product, supplier, and which U.S. Federal Government Agencies regulate you
  2. Request samples in advance of exportation to protect your own IPR
  3. Keep records proving you used Reasonable Care
  4. Confirm you’re using the correct HTSUS
  5. Confirm you’re using the correct value for your product
  6. Confirm you’re using the correct value Country of Origin
  7. Ensure you have a formal written compliance program
  8. Determine if there is an applicable Free Trade Agreement for your use
  9. If you receive a CBP 28 or CBP 29, immediately consult an expert to answer thoroughly
  10. If you receive a notice of detention or seizure notice from CBP, be PROACTIVE

Jen provided details of exactly how to follow these tips to ensure compliance, to learn more watch the full recording and read more information on the Diaz Trade Law website. David then stepped in to describe the FDA registrations necessary for compliance focusing on the four main registrations Manufacturing Facility Establishment (Annual), Food/Dietary Supplements, Medical Device Registration (Annual) and UDI and Drug Listings (Annual).

As Jen and David discussed, it is of the utmost importance to ensure that your drugs are listed or registered with the FDA as this is one of the most common rationales for detention, along with common labeling mistakes.

Finally, ensure that you are prepared and audit-ready for 2021 by understanding the CBP’s priorities, setting up an ACE account, requesting a mini audit and being prepared to quickly respond to the CBP Form 28 if Customs requests more information.

Learn more about import compliance and FDA compliance by watching our full webinar recording here or contacting [email protected] or [email protected].