FDA leadership has seen significant turnover in May 2026, including the resignation of FDA Commissioner Marty Makary, the appointment of Kyle Diamantas as Acting Commissioner, and a change at the top of CDER with Michael Davis stepping in as acting director after Tracy Beth Hoeg’s departure.

This is not a political story for manufacturers, it’s an operational one. Inspections and enforcement don’t pause when leadership changes. In periods of transition, what often shifts is predictability: how quickly decisions get made, how consistently expectations are interpreted, and how aggressively “fundamentals” get enforced.

What to expect: less predictability, more focus on basics

When an agency is managing internal transition, field staff generally lean on what is clearest and most defensible: the regulations, the evidence in front of them, and the quality system’s effectiveness. That means your inspection outcomes may hinge even more on your ability to show that your QMS is working.

What to do differently right now

1) Build a one-page “inspection narrative”
Create a short internal brief your team can align on before an inspection:

• Site/product scope
• Key processes and controls
• Major changes in the last 12 months (equipment, materials, suppliers, software)
• Current remediation items (and status)
• The 3–5 “highest-risk” topics and where the objective evidence lives

This reduces confusion and prevents the inspection from being defined by whoever explains things first.

2) Make Quality Unit ownership unmistakable
Inspectors look for whether the Quality Unit actually exercises authority in practice. Make sure you can show:

• Who approves/rejects critical decisions and where it’s documented
• How investigations drive CAPA (not CAPA-by-template)
• How effectiveness is verified and what triggers escalation

3) Pressure-test the “fastest-to-enforcement” systems
If you only have time for one internal audit sweep, prioritize:

• Data integrity (audit trails, access, contemporaneous records, review practices)
• Investigations/CAPA (root cause depth, scope, recurrence, effectiveness)
• Validation state (process validation, cleaning validation, CSV/software assurance where applicable)

4) Assume “we’ll follow up later” may not play well
In times of churn, FDA may be less tolerant of incomplete answers during an inspection. Your best defense is inspection-ready evidence: organized, accessible, and traceable to the record.

5) If you use AI anywhere in GxP, govern it
Even if you’re using AI only for drafting, ensure it’s treated as an input. Ensure it is supplemented with documented human review and approval where it touches controlled records. (This ties directly to FDA’s broader emphasis on Quality Unit accountability.)

Bottom line

Leadership turnover doesn’t mean softer oversight. It often means less predictability, and in that environment, “borderline” issues are more likely to go the wrong way. The winning strategy is to tighten the basics: clear story, clean evidence, effective CAPA, strong QU ownership, and inspection-ready documentation. Contact us here to see how we can help.