07.13.20
The U.S. Food and Drug Administration (FDA) said it intends to resume domestic on-site inspections of facilities it regulates, following the suspension of all inspections in March. The FDA will be operating under guidelines published by the White House, as well as those published by the Centers for Disease Control and Prevention, aimed at protecting workplace exposures to COVID-19 in non-healthcare settings.
Despite the agency’s pausing of on-site surveillance inspections in the U.S., the agency still conducted “mission-critical” inspections of facilities within each of the industries it regulates.
“We have had great success by suing a numer of tools as part of the agency’s risk-based approach to ensuring quality, including remote assessments and import alerts as well as other compliance requirements,” FDA said in a statement. “As the COVID-19 pandemic continued, we adjusted our processes and guidance as necessary to maintain the appropriate level of review to ensure the safety of consumer products, including hand sanitizer, diagnostic tests, and more.”
FDA will be using a rating system to determine where it will first begin conducting prioritized domestic inspections, which is informed by real-time data tracking the number of COVID-19 cases in a local area based on state and national data, which will also be made available to state inspectors who carry out inspections of FDA-regulated facilities under contract.
The July 20 date, however, is not final, FDA reports.
“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. In order to move to the next phase, we must see downward trends in new cases of COVID-19 and hospitalizations in a given area.”
Further, the availability of public transportation and other public services will be factored into determining when and where inspections will resume, FDA said.
"The health, safety and well-being of our investigators, as well as the public, are of the utmost importance to us," the agency said in a statement. "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."
Despite the agency’s pausing of on-site surveillance inspections in the U.S., the agency still conducted “mission-critical” inspections of facilities within each of the industries it regulates.
“We have had great success by suing a numer of tools as part of the agency’s risk-based approach to ensuring quality, including remote assessments and import alerts as well as other compliance requirements,” FDA said in a statement. “As the COVID-19 pandemic continued, we adjusted our processes and guidance as necessary to maintain the appropriate level of review to ensure the safety of consumer products, including hand sanitizer, diagnostic tests, and more.”
FDA will be using a rating system to determine where it will first begin conducting prioritized domestic inspections, which is informed by real-time data tracking the number of COVID-19 cases in a local area based on state and national data, which will also be made available to state inspectors who carry out inspections of FDA-regulated facilities under contract.
The July 20 date, however, is not final, FDA reports.
“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. In order to move to the next phase, we must see downward trends in new cases of COVID-19 and hospitalizations in a given area.”
Further, the availability of public transportation and other public services will be factored into determining when and where inspections will resume, FDA said.
"The health, safety and well-being of our investigators, as well as the public, are of the utmost importance to us," the agency said in a statement. "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."
