Negotiating an FDA Import Hold Strategies For Challenging FDA Findings

Held Dec. 1, 2009

An import hold could cost your FDA-regulated company hundreds of thousands, even millions, of dollars. Now, get expert advice on how you can negotiate with the FDA and Customs if your shipment is held up at its entry point.

The FDA loves imports alerts — they're quick, easy and stops products cold at the border. Plus, there's no need to get the courts or other agencies involved. It could be a long, cold winter for profits if you're slapped with one.

Apotex got hit with an import alert last August — and they’re still working with the FDA to get it lifted. Import alerts are just one action the FDA can take in the import hold process, including:  Notice of Sampling, Notice of Detention, Notice of Reconditioning or Relabeling and more.

In addition, the agency will soon roll out PREDICT, following field-testing in the L.A. office. Once that happens, every FDA-regulated importer of products or materials will face a new, higher level of scrutiny.

Ready for destruction of your shipments? Fines triple the value of your detained product? Loss of profits that could run into the millions of dollars?

With these obstacles, you need an experienced advisor, expert and counselor — one who’s been an insider at the FDA. That advisor is Benjamin England, Esq., former regulatory counsel to the FDA’s associate commissioner for regulatory affairs. Now in private practice, England has successfully negotiated the release of numerous FDA-regulated shipments awaiting delivery to U.S. drug and devicemakers.

What do the FDA and Customs look for when examining a shipment? How do you initiate communications with the FDA, who do you ask to speak to, what should you say in those initial contacts? What’s the best way to negotiate hold releases? When is the right moment to bring in outside help? How do you prepare for the informal hearing?

These questions — and more — will be answered in this information-packed 90-minute seminar. Sign up your entire team to listen in and discover:

  • How to read a Notice of FDA Action, identify and decipher issues, and plan an effective response
  • How the PREDICT system will influence the import alert and hold process
  • Strategies for challenging FDA findings — 5 that succeed, 5 to avoid
  • Best practices to assure your PREDICT profile doesn’t raise red flags with the FDA
  • 6 techniques for communicating with FDA personnel (when the clock is running on your shipments, slow communication and miscommunication can be lethal)
  • Understanding and complying with documentation requirements (paperwork in disorder is a surefire way to have your import held)
  • The levels of import holds and likelihood of a successful challenge at each
  • Import alerts — how to prevent the death penalty for your shipments and last-ditch strategies if it is imposed
  • And more

Start jotting down your questions now. This seminar is web-based and totally interactive, so you’ll have plenty of opportunity to email them and receive answers before the session ends.

You’d pay a pretty penny for 90 minutes of England’s time. Better to confer with him via the internet and pay just one low registration fee per company site — regardless of how many colleagues take part.

We think you’ll find this webinar invaluable. Andrea Kahn, a certified customs specialist with World Customs Brokerage, is among past attendees who applauded a past presentation on this topic. “I liked the step-by-step explanation of the FDA process,” she said. “Clear, concise and to the point.”

Why not register today?

  • Compliance officers
  • Executive management
  • Supply chain managers
  • Warehouse/shipping managers/supervisors
  • Consultants/service providers involved in imports
  • General/corporate counsel
  • Manufacturing directors and supervisors dealing with imported materials
  • Regulatory/legislative affairs professionals

Phone: toll free (888) 838-5578 (inside the U.S.) or +1 (703) 538-7600

Benjamin England is an attorney and founding member of Benjamin L. England & Associates, LLC. He is a 17-year veteran of the FDA, focusing his practice on FDA regulatory and compliance matters. While at the FDA, England served as the regulatory counsel to the associate commissioner for regulatory affairs. His FDA experience ranges from defending against FDA and Customs criminal investigations, inquiries and prosecutions to assisting clients in leveraging their risk management programs for medical device, drug or food distribution against FDA and Customs import clearance processes. Additionally, he guides client responses to FDA and USDA inspection and enforcement actions. He is a member of the Association of Food and Drug Officials and of the Bars of Florida, Maryland and the District of Columbia.

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