Don't Let a Reduced FDA Fool You: Enforcement Is Still Coming — And the Consequences Are Worse Than Ever

By Ricki A. Chase | April 2026 | RChase Consulting LLC

There is a narrative circulating in certain boardrooms and quality departments right now that goes something like this: FDA is distracted. They've lost thousands of employees. Inspections are down. We have some breathing room.

After 28+ years working in and around FDA — including as Director of Investigations — I want to be direct with you: that narrative is dangerous, and it will cost you.

Yes, FDA has experienced significant workforce reductions. Between 2025 and early 2026, the agency lost over 4,300 employees, including 170 staffers in the Office of Inspections and Investigations — among them, staff handling travel logistics for investigators working in Asia, South America, and other regions. Foreign facility inspection numbers fell sharply in 2025. The institutional knowledge walking out the door is real and cannot be replaced overnight.

But Warning Letters are still being issued. Recalls are still happening. And when FDA does show up — with a smaller, leaner, arguably more targeted enforcement posture — the agency comes prepared and is not forgiving.

Here is what the most recent enforcement activity is telling us.

The Data Integrity Crisis Is Not Over — It's Hiding

In February 2026, FDA issued a Warning Letter to A. Nelson & Co. Ltd., a London-based manufacturer of homeopathic drug products — including products labeled for children as young as two years old. I've read this letter carefully, and it reads like a case study I could present at any executive leadership training on what not to do.

The violations were textbook, and they were serious:

FDA found that the firm released drug products without conducting adequate microbial testing on every batch, extended expiration dates without supporting stability data, and — critically — had a quality unit improperly disposing of CGMP documentation. A handwritten sticky note indicating an out-of-trend result, discarded along with signed manufacturing records and unacceptable analytical forms, was found among trash. That sticky note became evidence.

This is data integrity failure at its most fundamental level — not a software glitch, not an electronic audit trail gap, but the physical destruction of records that should have triggered formal investigations.

What struck me most in FDA's response to the firm's corrective action plan was this: the agency explicitly called out that the company's independent consultant audit was not scheduled until May 2026, stating that this represented an excessive delay given the extent of the data integrity violations observed. FDA further noted that the company had been conducting its own corrective actions for eight months without any external oversight — and that this arrangement failed to provide adequate assurance.

Let me translate that from regulatory language into plain English: FDA does not trust you to fix a data integrity problem by yourself.

As someone who has conducted and overseen hundreds of inspections and investigations, I can tell you that this posture from the agency is entirely consistent with how I would have approached it. Data integrity violations are not isolated quality events. They represent a systemic breakdown in the culture of quality, and the FDA knows that internal CAPAs written by the same team that committed the violations are almost never sufficient on their own.

Sterility Assurance: The Recall That Should Have Been Prevented

In March 2026, the FDA initiated a Class II recall of over 3.1 million units of eye-drop products manufactured by K.C. Pharmaceuticals, including Artificial Tears, Dry Eye Relief, Ultra Lubricating Eye Drops, and Redness Relief. The basis: lack of assurance of sterility.

Note the careful language. This is not a confirmed contamination event. There were no reported injuries cited. But the recall happened anyway — because assurance of sterility is not optional, and a gap in the validation, monitoring, or procedural discipline surrounding a sterile manufacturing process is sufficient grounds for regulatory action.

This distinction matters enormously and is frequently misunderstood by management teams who are not steeped in FDA thinking. In the regulatory framework, sterile products are not sterile because they haven't been found to be contaminated yet. They are sterile because you can demonstrate — through validated processes, properly executed environmental monitoring programs, and disciplined quality systems — that contamination has been reliably controlled and excluded. When that demonstration breaks down, so does the entire regulatory basis for releasing the product.

The business consequences here extend well beyond the recall itself. FDA is likely conducting follow-up assessments of this facility's cleanroom practices and quality systems. A Form 483 or a Warning Letter could follow.

A Class II recall of 3.1 million units could have been prevented. In my experience, these situations rarely emerge from a single bad day. They develop over months — sometimes years — through gradual erosion of quality system rigor, deferred validations, environmental monitoring programs that are technically in place but not critically reviewed, and management that treats quality investment as overhead rather than insurance.

The Broader Enforcement Trend: Smaller FDA, Sharper Focus

Here is the strategic reality that every quality and regulatory leader needs to sit with right now.

FDA's inspection capacity has been strained. Foreign facility inspection numbers dropped significantly in 2025 — in some months by nearly half — following the workforce reductions in the Office of Inspections and Investigations. The loss of travel coordination staff for international investigators had immediate operational effects.

But this is not the same as FDA looking the other way.

What I am observing, and what the recent Warning Letter cadence reflects, is an agency that is triaging. With fewer resources, the FDA is making harder choices about where to focus its enforcement energy. That means the inspections that do happen — domestic and foreign — are likely to be more targeted, more technically prepared, and less forgiving of firms that have not been maintaining their systems between visits.

For regulated companies, this cuts both ways. Yes, your probability of being inspected in any given quarter may be somewhat lower. But if you are inspected, the expectation that you have been maintaining a state of continuous compliance — not just scrambling at audit time — has never been higher.

I spent years at FDA preparing investigators and executing national enforcement programs. I know what the agency looks like from the inside when it is operating under resource constraints. The answer is not complacency. The answer is prioritization of the highest-risk targets — and firms with known data integrity histories, prior 483 observations, or products in high-risk categories (sterile injectables, homeopathics, pediatric products, combination products) are exactly the kinds of targets that rise to the top of the list.

What Leadership Needs to Do Right Now

The current environment is not a reprieve. It is a window — and how you use it will determine whether the next FDA interaction is a clean inspection or a remediation crisis.

From my vantage point, the most pressing priorities for quality and regulatory leadership in pharma, device, biotech, and combo product organizations are:

Conduct an honest data integrity self-assessment. Not a checkbox exercise, but a genuine forensic review of how data is created, modified, reviewed, and retained across your operations. The A. Nelson case is a reminder that FDA will find what you have been avoiding looking at.

Evaluate your sterile or aseptic manufacturing controls with fresh eyes. If your environmental monitoring program, media fills, or cleaning validation has any open items, deferred reviews, or unresolved trends — address them now. The K.C. Pharmaceuticals recall is a case study in what happens when "assurance" is assumed rather than demonstrated.

Don't wait for an investigator to find your quality system gaps. With FDA resources constrained, firms that conduct rigorous internal audits and mock inspections — and then actually remediate findings — are building genuine competitive and regulatory advantage. Firms that use reduced inspection frequency as a reason to defer quality investments are accumulating risk.

Take your CGMP consultant obligations seriously. FDA continues to recommend — and sometimes require — independent, qualified CGMP consultants as part of enforcement responses. The agency's explicit criticism of the A. Nelson timeline for engaging external oversight should be a signal to any firm currently managing significant CAPAs without independent verification.

A Final Word

The FDA I worked for and the FDA that exists today are operating under very different resource conditions. But the fundamental expectation has not changed: manufacturers are responsible for producing safe, effective, quality products — not because an investigator might show up, but because patients depend on it.

I built my career on the principle that the best compliance programs are not reactive. They are built by leaders who understand the regulatory framework deeply enough to see risks before they become violations, and who have the organizational courage to act on what they see.

If your organization is navigating a Warning Letter response, preparing for an upcoming inspection, or honestly not sure where your quality system vulnerabilities are — I would welcome a conversation.