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

Recipharm has been building its capabilities in sterile injectable and inhalation drugs. Now it is buying a CDMO that manufactures devices for both.

The FDA has slapped the parent of Dollar Tree stores with a warning letter saying some CMOs that made its OTC products were among the world's worst.

GSK expects Shingrix supplies to rise slightly in 2020, but the real "step change" will come in 2024 with a brand-new manufacturing facility.