The number of inspections of foreign manufacturers carried out by the FDA this year could rise by 50%, according to a former agency official.

Benjamin England, founder of consultancy FDAImports.com, said that he expects the agency to knock on the doors of more facilities, particularly in China, India and Mexico this year.

The FDA has put considerable resources into opening offices abroad over the past two years after a Government Accountability Office (GAO) report revealed, in January 2008, that the agency had inspected relatively few foreign manufacturers. Controversially, the least inspected major country was China, which also had the most companies exporting class II and III devices to the US.

The GAO report set in train a series of events which led to the FDA opening 10 international offices, the first of which was in China, followed by offices in India and Europe. Most recently, on December 15 2009, the FDA opened an office in Mexico City (www.clinica.co.uk, December 16 2009).

“The FDA does have more people in foreign countries now,” Mr England told Clinica. “They won’t be doing the inspections but they will be able to facilitate arrangements between the agency and foreign governments to speed things up.” He said he expects that the agency will increase the number of trips they make, and increase the number of inspections “maybe by 50%”.

Mr England also told Clinica that the FDA will take a closer interest in registrations.

“Most drug and device companies are struggling with the registration requirements. Not that they are new but that these filings have to be submitted through an electronic system which is inartful at best,” he said.

It takes several weeks for a company to become validated to use the system, which catches some companies out, causing a delay of their products entering the US when they finally get round to seeking registration, Mr England noted.

On top of this, the FDA is starting to increase the overview of the parties in the supply chain, with the agency looking for evidence of listing all along the chain rather than just from the seller.

Mr England also said that the agency is more often looking for evidence of sterility, for example with surgical instruments. He said the agency’s stopping and sampling of products was causing delays of several weeks.

Compliance officers in the field and the CDRH were aware of the delays. But companies that raise concerns can be told by the compliance officer to speak to the CDRH which, in turn, tells the company it has to speak to the compliance officer, Mr England said.