FDA Warning Letters Up 96% — Here's What That Means for You
QMS.Coach Newsletter
Week of December 3, 2025
60 Days Until QMSR. Are You Ready?
The countdown is on.
On February 2, 2026, the FDA's new Quality Management System Regulation (QMSR) takes effect—and there are no extensions coming. If you're still running your QMS under the old QSR framework, you have exactly 60 days to close the gap.
This isn't just a paperwork update. It's a fundamental shift in how FDA will inspect your facility, what records they can access, and what terminology they expect to see in your documentation.
Here's what you need to know right now.
What's Actually Changing
1. New Inspection Process
The Quality System Inspection Technique (QSIT) that FDA investigators have used for decades? It's being withdrawn on February 2, 2026. A new inspection process aligned with ISO 13485 takes its place.
2. Your Audit Reports Are No Longer Protected
Under the old QSR, you could keep management review records, internal quality audits, and supplier audit reports away from FDA inspectors. That exception is gone. FDA will now have authority to review these documents during inspections.
3. Terminology Overhaul
If your documentation still references "Device Master Record (DMR)," "Design History File (DHF)," or "Device History Record (DHR)"—those terms don't exist in QMSR. You'll need to adopt ISO 13485 terminology like "Medical Device File (MDF)."
4. Enhanced Labeling & Packaging Requirements
New Section 820.45 requires detailed procedures for labeling and packaging operations. FDA has flagged device recalls related to labeling issues year after year, and they're tightening the screws.
FDA Enforcement Is Surging
Let's talk about what's happening on the enforcement side—because the numbers should get your attention.
In FY2024, FDA issued 47 warning letters to medical device companies. In FY2023? Just 24.
That's a 96% increase in one year.
CAPA violations remain the #1 cause, appearing in over 60% of warning letters. But here's the insight that matters most:
"It's not the 483 that triggers the warning letter—it's the response."
A thorough, well-prepared response to a Form 483 can resolve concerns before they escalate. A weak or delayed response almost guarantees a warning letter will follow.
With FDA inspections intensifying under a May 2025 Executive Order—including unannounced inspections for foreign manufacturers—now is not the time to be caught unprepared.
Industry Readiness: The Sobering Reality
According to Greenlight Guru's 2025 State of the Medical Device Industry Report:
- Only 16% of companies report being highly prepared for QMSR
- 62% of large companies struggle with siloed data
- 43% still rely on outdated tools for quality management
But there's a silver lining: companies that prioritize collaboration are 6x more likely to meet their quality objectives.
The takeaway? Your QMS isn't just a compliance checkbox—it's a competitive advantage.
Your December Action Checklist
With 60 days remaining, here's what to prioritize this month:
☐ Complete a QMSR gap analysis — Compare your current QMS against ISO 13485 requirements
☐ Update your terminology — Replace QSR terms (DMR, DHF, DHR) with ISO 13485 equivalents
☐ Prepare your audit documentation — Management reviews, internal audits, and supplier audits will be fair game for FDA
☐ Brief your team — Make sure everyone understands the new inspection process coming February 2
☐ Review your CAPA procedures — With CAPA violations driving 60%+ of warning letters, this is your highest-risk area
How Ready Are You?
Not sure where your gaps are?
Take our free 5-minute QMSR Readiness Assessment and get an instant score showing exactly where you stand—plus a prioritized action plan for the next 60 days.
Or if you'd prefer to talk through your situation directly, reply to this email to schedule a 15-minute call.
One More Thing
The FDA isn't slowing down. They're deploying AI internally (yes, really—they built a chatbot called "Elsa" powered by Anthropic's Claude), ramping up inspection activity, and expecting manufacturers to meet higher standards.
The good news? You still have time. But 60 days will disappear faster than you think.
Let's make sure you're ready.
— Neel Tiwari
Founder, QMS.Coach
P.S. — If you found this useful, forward it to a colleague who's also navigating the QMSR transition. The more prepared our industry is, the better for everyone.
QMS.Coach LLC
AI-powered compliance coaching for MedTech startups
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