FDA advises on cargo, warehouse theft prevention and response

The FDA wants all drugmakers to have a plan for responding to cargo and warehouse thefts. "Swift action is essential," says the regulator in a letter to manufacturer, wholesaler, pharmacy, device and infant formula trade associations.

In yesterday's letter, acting assistant commissioner Michael Chappell writes that the FDA will determine the appropriate public health response to a theft, and that in some cases the response may even include market withdrawal for products shipped before the theft that have the same lot numbers as those stolen.

"We would like you to promptly notify FDA's Office of Criminal Investigations as soon as possible when a theft has occurred," Chappell writes.

Manufacturers have a "fundamental responsibility" to continuously review their warehouse physical security and security practices, says. And they should ensure that security practices of supply chain partners are up to snuff. "You need to be one-step ahead of thieves in securing your warehouses and product transport."

In the event of a theft, the FDA wants the victim to quickly post a notice on its website or issue a press release.

- here's the letter

Suggested Articles

Transporting pharmaceutical products at <-60C for more than 96 hours has seemed an insurmountable challenge. TOWER’s solution has solved the problem.

Roche will spend $500 million for a new global manufacturing logistics hub in Canada that will eventually employ 500 workers in Ontario.

Fledgling Indiana CDMO Incog BioPharma Services is shelling out $60 million to get its first manufacturing facility off the ground.