date:May 31, 2016
Office of Regulatory Affairs, FDA has approximately 2,000 investigators to handle an increasing number of imports, and there is ongoing concern about how they will be able to complete the additional foreign inspections called for under the FSVP rule.
The question of what is enough has long been an issue, Breen said. I do know that one aspect of FSMA is that FDA has told Congress that it does not have the resources to do foreign inspections. By next year, there are supposed to be 9,000 for