Inspection Readiness: What FDA Warning Letters Can Teach Us

Inspection readiness is not about having a perfectly arranged inspection room or teaching people what to say when an FDA inspector arrives. It is about knowing whether the study can stand up to scrutiny.

In an oncology trial, an inspector can start with one patient record and quickly move through eligibility, treatment, imaging, safety, source data, EDC entries and sponsor oversight. If the evidence does not connect, a small issue can become a much bigger one.

What recent FDA warning letters show

A recent FDA inspection at an Indian clinical site is a good example. The site was conducting a liposomal doxorubicin study in patients with advanced ovarian cancer. FDA found that all three enrolled subjects had received aprepitant, even though the protocol restricted certain CYP3A4/CYP2D6 inhibitors.

The site's explanation was that aprepitant was routinely used before chemotherapy. That may make sense from a clinical practice perspective, but it did not meet the study protocol. FDA was concerned because the medication could affect the pharmacokinetic assessment and therefore the reliability of the study data.

FDA also identified problems with the informed consent language, including wording that could lead subjects to believe the study drug had already been shown to be effective. These are the kinds of issues that become difficult when they are discovered during an inspection rather than during routine oversight.

Another FDA oncology inspection found a patient enrolled without meeting an eligibility requirement and continued on treatment after documented disease progression. FDA also identified genetic sample collection without the required separate consent.

The lesson is simple: inspection readiness starts with the study itself, not with the inspection date.

How VedX Clinical Helps

At VedX Clinical, we look at the study the way a regulator may look at it. We trace critical requirements from the protocol through source data, EDC, monitoring and sponsor oversight. We look for gaps in eligibility, informed consent, safety, endpoint assessments, vendors and critical processes.

More importantly, we do not stop at identifying findings. We help teams understand the issue, assess its impact, implement remediation and CAPA, and prepare the evidence needed to demonstrate that the problem has been addressed.

The goal is not to make the study look perfect. The goal is to know where the risks are before the regulator finds them.

Prepare before the inspection

Find the gaps. Fix the risk. Face the inspection.

FDA source documents

• FDA warning letter: Sourav K. Mishra, M.D. / All India Institute of Medical Sciences, April 29, 2026
• FDA warning letter: Shirish M. Gadgeel, M.D., September 4, 2025