Have routine FDA inspections resumed in any capacity? If not, what can industry members expect in 2021 amidst COVID-19? At the onset of the COVID-19 pandemic in 2020, FDA announced a temporary halt to on-site facility inspections. With few exceptions, the agency made clear it would remove itself from this aspect of its usual operations in order to prioritize the health of its own employees and those of inspected firms. That was back in March 2020.
Since then, much time has passed, and at the time of this writing COVID-19 vaccines are in their early stages of U.S. deployment.
In summer 2020, FDA announced it had resumed inspections for “mission-critical situations and other activities,” while the vast majority of routine inspections laid in waiting. Mission-critical situations can apply to food and dietary supplement facilities and may include situations of consumer complaints with reports of injury as well as follow-up inspections if required.
FDA has alluded to the use of remote tools for conducting facility inspections during COVID as part of a risk-based approach, but such work is likely be limited and cursory in nature, such as for basic recording keeping, sharing of documents, and to ascertain that manufacturers have food-defense plans in place. Virtual inspections would likely increase the agency’s ability to perform a large number of inspections even after the current health threats diminish, but there are security issues to consider.
In lieu of government inspections, remote or in person, industry members are advised to continue with their own due diligence and recordkeeping, using the various resources available to them. Projects like the Supplement Safety & Compliance Initiative (SSCI) aim to streamline industry regulations and best practices so that product manufacturers can guarantee quality assurance of products in ways outside of FDA’s current scope of enforcement. People are still interested in making sure they’ve got the right product on the shelves” said CEO and President of the Natural Products Association (NPA).
Industry members are encouraged to reach out to organizations like AHPA and NPA for guidance on how best to self-regulate their businesses during COVID and after.
It’s reasonable to assume that FDA will eventually try to make up for its backlog of inspections, but industry members should expect the same rigor of pre-COVID inspections when they recommence for everyone, whether virtual or otherwise. Many questions remain as to how inspections will start up again. Unfortunately, such questions will likely remain unanswered for a bit longer as COVID-19 relief develops. Stay ahead of the curve and on top of your supplements inventory with HawkScanner. Upload your inventory and make sure your ingredients are within FDA guidelines. Sign up today to start your free trial, and take a look at our tiered subscriptions to unlock premium features like live monitoring and automatic updates.