Upcoming Webinar on July 29: Avoiding Common Pitfalls During FDA Inspections

As we have previously covered, FDA has long been on the receiving end of criticism about its lagging foreign inspection program.  The focus of the criticism has been that simply not enough foreign inspections are occurring at all and, when they do, they have historically been preannounced several weeks in advance.  With a preannounced inspection, the facility has time to correct known issues in advance, meaning FDA theoretically isn’t observing the true day-to-day operations of the site.  In response to this, FDA began conducting unannounced or short-notice inspections in China and India several years ago.

On May 6, 2025, FDA announced that intends to expand the Office of Inspection and Investigations Foreign Unannounced Inspection Pilot program “to ensure that foreign companies will receive the same level of regulatory oversight and scrutiny as domestic companies.”  While the details of the expanded program are vague, this is a good opportunity for stakeholders across FDA-regulated industries around the world to ensure they are inspection ready.  On July 29, 2025, ProPharma and HPM’s Kalie E. Richardson will be participating complimentary webinar on Avoiding Common Pitfalls During FDA Inspections. to discuss common FDA inspection findings and how they can be avoided.  Please join us for the live session on July 29 at 8-9 am EDT / 2-3 pm CEST / 5:30-6:30 pm IST.