Import Detention a Real Concern for Firms Using Foreign Suppliers

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

The FDA has been emphasizing that firms should employ better component acceptance procedures to reduce product recalls.