date:May 31, 2016
ements, the agency may pursue regulatory action (e.g., Warning Letter, placing the importer on Import Alert).
Breen said FDA knows that the agency will need to work with staff on state, tribal and other levels to help with the enforcement piece of the puzzle. Thats why FDAis contracting with states (37 at last count) to get this done, he said.
Breen also said that he expects FDA to use a risk-based approach to enforcing the FSVP rule, meaning that it will focus its traditional activities t