Consider Import Detention Risk With Foreign Suppliers

As devicemakers move toward a global outsourcing model, firms should consider stockpiling supplies and product components because the FDA has come under pressure to bring foreign manufacturing sites into compliance, thereby raising the risks of import detention.

“The level of risk to you is immense with foreign suppliers because if they’re on detention, the product doesn’t get through at all,” Dennis Moore, former FDA investigator and president of consulting firm Auk Technical Services, said Oct. 25 during an FDAnews audioconference.

He said the FDA has no real process for placing a product on import detention; it basically does what it wants to do. Once a product is detained, it can take years to get the matter resolved.

Another approach firms can take to minimize the risk of import detention is to have multiple suppliers or vertically integrate. “It’s a little easier … for FDA to negotiate if it’s your company, but not always,” Moore said.

The audioconference, “Reduce Supply Chain Risks: How the FDA Expects You to Manage Outsourced Suppliers,” can be accessed at www.fdanews.com/conference/detail?eventId=1548.