FDA import hold 2

Help, my imported medical products are being held by US customs and the FDA. Now what?

Posted on October 16, 2013 · Posted in Imported Medical Products

One of the most frustrating experiences for any importer is knowing that their products have arrived into the united states, but customs is holding the goods for inspection. This is an obvious drain on sales activity can cash flow.

A serious problem faced by medical device and pharmaceutical manufacturers is receiving the dreaded alert from the FDA that your imported medical products are being held due to labeling adulteration or mistakes in shipping documentation provided by off-shore suppliers. An FDA hold usually lasts about 24-48 hours – but can go on for weeks, even months if the FDA’s initial request for information does not receive an immediate and complete response.

How can you company prevent these problems from happening in the first place?

1. Make sure your import documentation is accurate and complete. Use well respected shipping companies that have experience handling pharmaceuticals, biologics and medical equipment. A good resource: www.mohawkglobal.com

2. Ensure all imported items are shipped with appropriate FDA registration, clearance and approval documents. Any certificates of conformity for materials and bio-compatibility should be included.
Get to know how the US Customs PREDICT system works; this is a database system built to pin-point red flag imports if any suspicious paperwork or imports are entering the country.

Items such as correct product codes, country of origin, prior notice submissions (mainly for food) should all be a part of your standard documentation check list.

3. Make sure you perform due diligence on your off-shore medical suppliers. Assure your suppliers and their sub-suppliers are not listed on any of the FDA import red-lists. This will automatically lead to customs and FDA holds. Check on your suppliers here.

Photo: courtesy of FDA.gov