FDA Commissioner Dr Stephen Hahn, MD said the agency has worked to determine the safest and most appropriate time to resume prioritized domestic inspections of FDA-regulated facilities. Hahn added that the Agency is leaning on The White House Guidelines for Opening Up America Again and the Centers for Disease Control and Prevention (CDC) to provide guidance.
“Despite pausing on-site surveillance inspections in the US in March, our investigators have conducted mission critical inspections and other activities to ensure FDA-regulated industries are meeting applicable FDA requirements,” noted Hahn.
New rating system
The upcoming revised inspections will be carried out using a rating system to assist the agency in determining when and where it is safest to conduct prioritized domestic inspections. The inspections will be prioritized according to a rating system based on real-time state and national data to assess the number of COVID-19 cases in a given area. The system will generate an ‘advisory level’ based on the outcome of three metrics: phase of the particular state and county-level statistics on the current trend and intensity of infections.
The three main categories of regulatory activity at the county level will be: mission critical inspections only, all inspections with caveats to help protect staff who have self-identified as being in a vulnerable population and resumption of all regulatory activities.
Inspections will depend on trends in new cases
The agency notes that while they are aiming to restart on-site inspections the week of July 20, “Resuming prioritized domestic inspections will depend on the data about the virus’ trajectory in a given state and locality and the rules and guidelines that are put in place by state and local governments.”
Daniel Fabricant, PhD, President of the Natural Products Association (NPA) said he’s extremely happy about the move, adding the NPA has been pushing self-regulation “for a while now.”
Inspections will be pre-announced to ensure safety, with the exception of retail tobacco sites since those are undercover operations.
“CRN is pleased to learn the agency is making plans to resume routine facility inspections starting next week," said Steve Mister has been President & CEO of the Council for Responsible Nutrition (CRN). "We have been urging our members to be especially vigilant during the pandemic to assure their products maintain the highest levels of quality and their facilities adhere to cGMPs, but self-policing only works for companies committed to their consumers, so we are glad to know that FDA will begin its inspections as a backstop. We also applaud the announcement of selecting facilities based on risk. It’s time the agency targeted firms with histories of compliance issues or ones that make products with questionable supply chains. We have long advocated FDA should prioritize these firms for inspection, and perhaps the pandemic has led FDA to see the merits of this approach."
In order to move to the next phase of inspections, the agency said it will need to see a downward trend in new cases before upgrading an area to a less-stringent level.
“The health, safety and well-being of our investigators, as well as the public, are of the utmost importance to us,” said Hahn. “We will ensure our investigators are outfitted with personal protective equipment and are equipped with other necessary equipment to carry out their work while adhering to state and local guidance as well as applicable CDC guidance. We will continue to work to ensure our prioritized domestic inspections resume appropriately and as safely as possible.”
Larisa Pavlick, VP Global Regulatory and Compliance, United Natural Products Alliance, cautioned that the safer the state, the more likely an inspection:"We would also note that FDA will look at COVID-19 hotspots (Texas, Florida, Arizona) and will put these and other hotspots on a lower priority for FDA staff protection. So, it is reasonable to conclude that other areas such as Montana, the Northeast, and probably Utah, would be reasonably high on the safe side of that priority list. So, we urge our members in safer COVID-19 parts of the country to be aware that your chance of inspection is somewhat higher, in our view."
Questions loom overseas
While the move is a step in the right direction, industry leaders are voicing concerns about international supply. "CRN urges FDA to pay special attention to international supply chains, ingredient identity and purity validation during its domestic inspections until it is able to resume foreign inspections as well," said Mister.
Fabricant echoed a similar concern: “Our biggest fear is what’s going to happen to firms versus foreign firms. They’re obviously just doing domestic inspections first, that leaves a hole in the system. So how do we shore up that hole? With so much coming from overseas, how do we ensure that it’s safe?”
The FDA did not immediately respond to questions from NutraIngredients-USA.