FDA’s latest data should make any sponsor relying on a CDMO take a hard look at the site behind the application.
In its FY2025 Report on the State of Pharmaceutical Quality, FDA analyzed nearly 10,000 original applications and supplements received during FY2024 and FY2025 that required a facility assessment. As of May 2026, 28% had received a Complete Response Letter, and 43% of those CRLs were due to a facility withhold.
More than half of those facility withholds resulted from sites that already had OAI or potential OAI status. FDA also said many of those CRLs could have been prevented if the submissions had included only facilities with a compliant status.
That is a big deal.
A separate peer-reviewed analysis of publicly available CRLs for 43 novel therapeutics ultimately approved between 2020 and 2024 found facility deficiencies in 65% of the letters and CMC deficiencies in 51%.
If you are a sponsor, this changes how you should look at CDMO selection and oversight.
Capacity matters. Equipment matters. Technical capability, schedule, and cost matter. But so does the actual compliance condition of the site you are tying your product to.
What has FDA already seen there?
What is still unresolved?
Are the same problems coming back?
Are the CAPAs actually working?
Does the Quality Unit have real control?
And if something starts to slip, will you know early enough to do something about it?
For a critical program, a focused independent audit before committing to the site can be one of the least expensive ways to reduce that risk. It does not need to become a massive exercise. The goal is to get experienced eyes on the areas that matter most: inspection history, open remediation, repeat deviations, investigations, CAPA effectiveness, Quality oversight, microbiological controls, and whether the operation you are being shown matches the condition of the site.
We ask these questions because we have watched what happens when nobody does. Once the program is committed, the choices get harder and more expensive. Validation work is underway. Supply plans are built. Timelines have been promised. Moving the program may no longer be simple.
That is when the site’s compliance problem becomes your problem.
MEDVACON LIFE SCIENCES, LLC, we work with sponsors to get past the status updates and understand what is actually happening in the operation their program depends on. Sometimes that means a focused audit before selection. Sometimes it means taking a harder look at a site you are already committed to. Either way, the value is finding the problem while you still have options.
You can outsource manufacturing. You cannot separate your application from the compliance condition of the site that makes your product.