‘We’re staring at a backlog of inspections’

Remote regulatory assessments (RRAs) for food products (which includes dietary supplements) were established as a temporary program during COVID, to allow the agency to keep its finger on the industry pulse in some way.

For food, RRAs are a voluntary program: If the firm agrees to participate, FDA requests certain documents, reviews them, and then issues feedback.

Speaking at last week’s GRMA Summit in Chicago​, Dr Cara Welch, ODSP Director, explained that RRAs are an adjustment to FDA’s inspectional program.

“Based on experience to date, I suspect they will continue to be used even as we move into more traditional inspections,”she said. “But there’s more to be done. Putting together the maximum number of inspections plus RRAs, there are still legitimate concerns that we won’t really be getting the numbers we want to see in order to get a good picture of the compliance status of dietary supplement facilities.”

Indeed, pre-COVID, the FDA’s dietary supplement program had been running 500-600 facility inspections per year, which represents barely 5% of the 10,000 dietary supplements facilities in the system (during the COVID years of 2020 and 2021, the number of facility inspections dropped to less than 300).

“We’re staring at a backlog of inspections that weren’t able to be completed in the past couple of years,”she said.

“Within FDA always, there’s the desire to do more inspections and to do the right inspections and have the biggest impact on public safety and product quality.”

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