Remote Assessments A Welcome Option For US FDA, But They’re Not Every Firm’s First Choice

“We're looking to expand the use of this tool make it a more routine part of our operations going forward,” says Michael Dutcher, deputy director, ORA Office of Human and Animal Food Operations. “In general, the response from industry has been pretty positive” about RRAs.

Remote regulatory assessments aren’t the first choice for everybody in dietary supplement manufacturing, even though those firms have that as an option to regulatory inspectors visiting their facilities.

RRAs, which the Food and Drug Administration turned to during travel restrictions imposed at the onset of the novel coronavirus...