Prior to the COVID-19 pandemic, during fiscal year (FY) 2019 (October 1, 2018, through September 30, 2019), the FDA conducted 7,266 GMP inspections of registered drug, device and biologics establishments.
When the pandemic hit hard in March 2020, the agency paused most inspections to safeguard its employees. Then in June 2020, conducted only “mission-critical” domestic and foreign inspections and “prioritized domestic inspections” through March 2021.
The pandemic created a tremendous backlog of inspections. In FY 2021, the FDA conducted only 2,282 GMP inspections of registered drug, device and biologics establishments; a nearly 70% decrease from FY 2019.
In its February 2022 report, the U.S. Government Accountability Office (GAO) highlighted “long-standing challenges” that have contributed to the inspection backlog outside of the pandemic, including a shortage of personnel who specialize in foreign inspections, and a reliance on translation services provided by the establishment being inspected.
With pressure on the FDA to resume its pre-COVID volume of inspections, the agency increased its GMP inspections from a low of 2,282 in FY 2021, up to 4,287 in FY 2022, issuing 2,422 Form FDA 483 citations.
With an eye on continued progress for drug and device quality and safety, the FDA has requested $24 million in its FY 2023 budget specifically to optimize inspections and enhance inspectional capacity. According to the agency’s press release:
“The budget request increases support for the recruitment and training of new FDA investigators to improve the efficiency of the agency’s human and animal food and medical product inspectional operations. With additional personnel, as well as expanding the use of new and existing inspectional tools, the FDA will enhance its inspectional capacity and build on the efforts to keep pace with rapidly expanding industry including medical counter measures and advanced manufacturing.” (Compliance Dashboard, Inspections, FDA, accessed October 3, 2022, https://datadashboard.fda.gov/ora/ cd/inspections.htm )
Your quality management processes are under the watchful eye of the FDA and other regulators, and it is only a matter of time until you are subject to an inspection, whether planned or unplanned. As the FDA ramps up its surveillance activities to address the COVID-19 pandemic backlog, the likelihood of an inspection grows.
To learn more about FDA’s 483’s and warning letters, download this whitepaper: 483s and Warning Letters: Building a quality driven foundation through technology.