CDER Chief on Inspection Backlog: 2025 Will Be a 'Crucial Year'
FDA's CDER director Patrizia Cavazzoni on Monday stressed that the agency will be ramping up its inspections in 2025 to reduce its pandemic backlog.
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Quality leaders and anyone else responsible for compliance assuredness and inspection readiness should read Zachary Brennan's new piece in Endpoints News.
On the heels of an AP report revealing the FDA's still-massive backlog of inspections trailing the pandemic, CDER director Patrizia Cavazzoni, at a conference for manufacturers in Washington on Monday, said that this year, “we will have conducted significantly more surveillance inspections” from last year.
Even more importantly, she called 2025 “a crucial year for us to really get back to where we would like to be” and noted that the FDA uses a risk-based approach to selecting site inspections. She also stated that for-cause inspections have returned to pre-pandemic levels.
In case you're not an Endpoints News subscriber, here are a few of the most pertinent excerpts:
WASHINGTON, DC — CDER director Patrizia Cavazzoni on Monday stressed that while the agency is looking to reduce its backlog of surveillance inspections, pre-approval inspections will continue to uncover cGMP issues, lamenting that the timing of those uncoverings is “obviously not optimal.”
On the backlog of surveillance inspections conducted by the FDA, which has persisted since the pandemic, Cavazzoni said this year, “we will have conducted significantly more surveillance inspections” from last year. Speaking at a conference for manufacturers in Washington, she called 2025 “a crucial year for us to really get back to where we would like to be,” and noted that the FDA uses a risk-based approach to selecting sites for inspections. She also noted that for-cause inspections have returned to pre-pandemic levels.
User fee programs for new drugs, biologics and biosimilars don’t fund surveillance inspections, which Cavazzoni said is not only bad for the agency, but also that “it’s not a good situation for sponsors because I think that more surveillance inspections” in those facilities would actually prevent issues in the first place, instead of emerging during pre-approval inspections.
In contrast, Cavazzoni noted that the generic drug industry does fund such surveillance inspections, which she said has helped it overcome “some maturation growing pains” as the industry transitions from making solid oral drugs to more biosimilars and complex generics.
Surveillance inspections also can’t be conducted remotely, and on-site inspections have steadily grown since the pandemic in terms of the cause for a warning letter.
Are you ready for the ramp-up in FDA inspections?
With pressure on the FDA to clear its inspection backlog in 2025, companies across FDA-regulated industries must be prepared. Revelations from the FDA’s leadership like this and what we’re seeing ourselves in terms of the number of firms ramping up their audits and mock inspection programs clearly signal compliance is a huge priority moving into 2025.
Given that most firms we work with do their audit and mock inspection planning in Q3 and Q4, we want to let you know that this year has been the busiest by far for assessment planning in recent years. We're seeing RA/QA leaders prioritizing mock inspections, internal site audits, and vendor/supplier audits well into 2025.
If you have yet to schedule your audits and other compliance assuredness projects, demand for auditors and mock inspectors — particularly from former FDA professionals — is at an all-time high. We urge you to contact us as soon as possible to make sure resources are available for your audit schedule.
If we haven't yet partnered on project support, we provide end-to-end audit support and intensive, comprehensive mock FDA inspections that not only mirror real inspections but go deeper — giving you the insights, corrections, and readiness you need before the FDA walks through your doors. With a staff of 2,500 resources worldwide, over 225 of whom are former FDA, we're the partner firms work with when they want deep domain expertise and the peace of mind that comes with a partner whose commitment to quality and integrity reflects their own.
Whether you need a complete audit program design, full execution, or specific audit support, we're here to help. Drop us a line to start the conversation.
Links and resources
Our interview with former FDA investigator and consultant, Christopher Smith
Our interview with Divya Gowdar on audit and FDA inspection readiness best practices
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