SILVER SPRING, Md.,
July 10, 2020 /PRNewswire/ -- The
U.S. Food and Drug Administration has been thoughtfully and
deliberately determining the safest and most appropriate time to
resume prioritized domestic inspections of FDA-regulated facilities
and other associated activities since we first announced
postponement in March. The White House Guidelines for Opening Up
America Again are providing us a roadmap for optimizing operations
and new work arrangements, as well as the Centers for Disease
Control and Prevention (CDC) guidance for protecting workplace
exposures to COVID-19 in non-healthcare settings.
Despite pausing on-site surveillance inspections in the U.S. in
March, our investigators have conducted mission critical
inspections and other activities to ensure FDA-regulated industries
are meeting applicable FDA requirements. We have had great success
by using a number 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. 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.
At the same time, we have been closely monitoring reopening
criteria established at the federal, state or county levels and
planning to identify when and where to resume domestic inspections,
prioritizing the inspections based on risk and other factors.
To arm our investigators with the most reliable and accurate
information, the FDA has developed a rating system to assist us in
determining when and where it is safest to conduct prioritized
domestic inspections. The COVID-19 Advisory Rating system (COVID-19
Advisory Level) uses real-time data to qualitatively assess the
number of COVID-19 cases in a local area based on state and
national data. We are also making the Advisory Level data available
to our state partners who carry out inspections of FDA-regulated
entities on the agency's behalf under contract.
The Advisory Level is based upon the outcome of three metrics:
Phase of the State (as defined by the White House guidelines) and
statistics measured at the county level to gauge the current trend
and intensity of infection. When each of these is taken into
consideration, the FDA will identify regulatory activities that can
occur within the given geographic region. 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.
At this time, we are working toward the goal of restarting
on-site inspections during the week of July
20. However, 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. Our ability to resume is also
affected by other services that have been curtailed by the
pandemic, such as public transportation. The availability of these
services will be an important factor in how we determine resuming
domestic inspections.
The FDA has also determined that, for the foreseeable future,
prioritized domestic inspections will be pre-announced to
FDA-regulated businesses. This will help assure the safety of the
investigator and the firm's employees, providing the safest
possible environment to accomplish our regulatory activities, while
also ensuring the appropriate staff are on-site to assist FDA staff
with inspection activities. Due to the nature of retail tobacco
inspections, these inspections will not be pre-announced when they
resume, as they are undercover operations where the retailer is
unaware an inspection is taking place.
The health, safety and well-being of our investigators, as well
as the public, are of the utmost importance to us. 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.
Additional Resources:
- FDA: Novel Coronavirus (COVID-19)
Media Contact: Jeremy
Kahn, 301-796-8671
Consumer Inquiries: 888-INFO-FDA
The FDA, an agency within the U.S. Department of Health and
Human Services, protects the public health by assuring the safety,
effectiveness, and security of human and veterinary drugs, vaccines
and other biological products for human use, and medical devices.
The agency also is responsible for the safety and security of our
nation's food supply, cosmetics, dietary supplements, products that
give off electronic radiation, and for regulating tobacco
products.
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SOURCE U.S. Food and Drug Administration