What Derek Smith’s FDA Reports Reveal About FDA Compliance Priorities
When the FDA updates its guidance or enforcement trends, the entire life sciences industry pays attention. But here’s the thing: you don’t have to wait for official announcements to understand what the agency really cares about. You can already see it in the fieldwork of inspectors like Derek Smith.
Smith, one of the FDA’s more active investigators, has built a detailed track record over the years of inspections. His reports reflect what the agency is prioritizing right now and where companies are most likely to fall short.
If you’re responsible for quality, regulatory affairs, or compliance in a pharmaceutical, biotech, or medical device company, understanding patterns in his findings can help you strengthen your operations before the FDA shows up.
Who Is Derek Smith? Why His Reports Are Worth Watching
Derek Smith is a senior FDA investigator with extensive experience in drug and device manufacturing inspections. He has conducted hundreds of inspections across the United States and abroad, reviewing everything from sterile manufacturing environments to supplier oversight programs.
Here’s a quick look at his record:
- Total inspections: 1
- Form 483s issued: 1
- Warning letters: 0
- Geographic reach: Primarily US-based, with significant activity in India, China, and Canada
These numbers are telling. The 82 Form 483s suggest he consistently identifies deficiencies. However, the relatively low number of warning letters indicates that many companies are able to correct issues early, which is exactly what you want.
What Derek Smith’s Inspections Reveal About FDA Priorities
By digging into the specifics of his reports, we can see where the FDA’s current compliance spotlight really shines. Here are the four themes that keep coming up.
- Data Integrity: The FDA’s Top Priority
One of the most frequent findings in Derek’s inspections is weak data integrity. Missing records, uncontrolled spreadsheets, backdated entries — they all show up.
Why this matters: Since the FDA issued updated guidance on data governance last year, they’ve doubled down on ensuring manufacturers adhere to ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available).
What you can do:
- Audit your systems for gaps in electronic records and access controls.
- Retrain staff on proper documentation habits.
- Build periodic spot checks into your QA program.
- Cross-Contamination Control Is Non-Negotiable
In multi-product facilities, Derek often finds improper cleaning validation and inadequate segregation. Shared HVAC systems, insufficient changeover procedures, and lax gowning practices all contribute.
Why this matters: High-profile contamination cases in sterile manufacturing have made this a hot-button issue with the agency.
What you can do:
- Revalidate your cleaning and sanitization protocols.
- Review equipment uses logs to ensure proper segregation.
- Make sure physical barriers and pressure differentials meet standards.
- Supplier Oversight Needs Strengthening
Derek’s reports also flag weaknesses in how companies qualify and monitor suppliers, particularly for raw materials sourced overseas.
Why this matters: Recent warning letters highlight how poor supplier controls can undermine product quality and lead to recalls.
What you can do:
- Formalize supplier audits and scorecards.
- Require Certificates of Analysis and verify periodically.
- Establish contingency plans for critical suppliers.
- CAPAs Must Be Effective, Not Just Documented
CAPA programs come up in almost every inspection, and Derek’s no exception. Too often, he cites repeated deficiencies that prior CAPAs failed to fix.
Why this matters: The FDA wants to see that CAPAs actually resolve problems, not just fill paperwork.
What you can do:
- Track and measure CAPA outcomes.
- Assign clear ownership and deadlines for each action item.
- Periodically review recurring deviations for trends.
What His Inspections Suggest About Risk Today
When you step back, Smith’s record offers a few broader lessons about where the FDA is concentrating its efforts:
- Warning letters are avoidable: Even with 82 Form 483s issued, only five escalated. Prompt corrective action makes a difference.
- Overseas scrutiny is growing: Nearly 30 percent of his inspections in the last two years were outside the US. International sites remain under close watch.
- Duration signals depth: While some inspections finish in just a few days, others stretch over 10. Longer inspections often point to deeper, systemic concerns.
How Compliance Teams Can Stay Ahead
Here’s what you can do to align your practices with the areas Smith’s findings reveal:
- Audit your data practices now: Ensure your electronic records are secure, accurate, and updated in real time.
- Refresh risk assessment: Document them, revisit them regularly, and make sure they cover all relevant scenarios.
- Evaluate vendor oversight: Check your contracts, audit schedules, and quality agreements with CMOs and suppliers.
- Focus on contamination control: Review your environmental monitoring data and personnel practices.
- Invest in training: Keep staff up to date on SOPs and maintain thorough records of their qualifications.
Why Individual Inspector Patterns Matter
Not all FDA inspectors are alike. Each brings their own experience and focus areas to inspections. By analyzing their records, as we’ve done here with Derek Smith, you can anticipate the kinds of issues your site might face and prepare accordingly.
Tools like Atlas Compliance make this process easier. You can track specific inspectors, benchmark against peers, and get real-time alerts about enforcement trends all in one place.
How to Act on These Insights Today
Here are three concrete steps you can take right now:
- Audit for the big four: Assess your site against the priorities we outlined above — data integrity, contamination control, supplier oversight, and CAPAs.
- Monitor trends: Use a regulatory intelligence platform to stay on top of inspector findings and enforcement shifts.
- Train your team: Make sure everyone, from operators to QA, understands these focus areas and how they apply to daily operations.
Proactive compliance is much less painful (and costly) than reactive fixes.
The Bottom Line
Derek Smith’s inspection record is more than a paper trail. It’s a roadmap showing exactly where the FDA is putting its weight in 2025 and beyond. By learning from his findings, you can tighten your processes, avoid costly missteps, and demonstrate your commitment to quality.
If you want a smarter way to monitor inspectors, benchmark your performance, and track enforcement trends in real time, Atlas Compliance can help. Our platform transforms FDA data into actionable insights, so you can stay one step ahead.
