By June 29th, the FDA is required to launch a pilot program to “increase unannounced foreign inspections” of facilities that manufacture, package, prepare, compound, label, or process a drug or device that is imported or offered for import into the United States. This mandate includes foreign companies whose products are sent to one or more other foreign establishments prior to importation into the U.S.
The provisions for the pilot program and the inclusion of companies that do not export directly to the U.S. are set out in the Food and Drug Omnibus Reform Act (FDORA) - contained in the Consolidated Appropriations Act of 2023 - signed by President Biden on December 29, 2022. FDORA requires the pilot program to be launched within 180 days of the Act’s signing date, which puts it squarely on the calendar for June 29, 2023.
The phrase “increase unannounced foreign inspections” sounds significant, yet the goal of this $10 million program is to gather and compare information from announced and unannounced inspections and then to issue a report with the FDA’s findings and recommendations. So, get ready for this!
There has long been concern that the FDA’s practice of conducting unannounced inspections of U.S. facilities versus announced-well-in-advance inspections of foreign facilities was producing uneven results, with the specter that the announced-in-advance foreign inspections were not effective. In December 2021, Congress directed the agency to conduct unannounced inspections in India and China in FY2022.
In December 2022, as noted above, Congress has directed the agency to determine whether, and how, announced and unannounced inspections differ in terms of the number and types of violations, as well as whether barriers exist to conducting unannounced inspections in foreign countries. I think it goes without saying what the results will be. Right??
It will take some time for the results to come in, but one thing is for certain: the FDA is squarely focused on conducting unannounced foreign inspections. During our years of inspection preparedness and remediation work with clients, our Quality Executive Partners experts have put a significant effort into supporting and teaching companies to sustain quality and organizational changes. The results have been “crystal clear” time and time again: it is achievable to get your quality operations in tight compliance while at the same time continuing commercial operations at a steady pace. To do so, you need to change the mindset at the leadership level and for that to permeate to those doing the work. As attitude reflects leadership, so does following their lead. Gambling that you can wait to do the right things in quality and manufacturing until you hear about an upcoming inspection is no longer an option. The time for quality is now, and it always will be.
QxP Founder and CEO Crystal Mersh’s career in pharma quality has spanned three decades and huge companies. Prior to founding QxP in 2012, Crystal has worked in leadership roles at Mylan, Novartis, Watson Pharmaceuticals, and Sanofi.
For more on the subject of quality in pharmaceutical manufacturing, read Crystal’s recent Pharmaceutical Online article,“Cost Of Quality: Worth Every Cent In Bio/Pharmaceutical Manufacturing.” You also might want to check out Crystal’s blog about why “Controls Aren’t Enough.”
