FDA Audit Finding
Every time a company receives an FDA 483, the technical findings are right there on paper.
But ask those closest to the issue what really happened—and they’ll tell you it wasn’t just the SOP, or the batch record, or the deviation investigation.
It was culture.
The silent decisions. The skipped conversations. The unspoken hesitations. These are the cultural risks that rarely show up in metrics—but always show up in hindsight.
At Compliance Insight, we’ve worked with hundreds of pharmaceutical, biotech, and medical device firms. We’ve seen firsthand that regulatory failures almost always have roots in cultural blind spots—and they’re often avoidable.
To help teams make culture actionable, we developed the TEACM Method—Train, Educate, Audit, Coach, and Mentor—a proven framework for transforming compliance culture from reactive to resilient.
Here are the Top 5 Hidden Culture Risks leading to FDA observations, and how TEACM addresses them before they become systemic.
- Silence During Problems
The Risk:
Team members spot potential issues—but stay quiet. Whether it’s fear of blame or just fatigue from a high-pressure environment, silence becomes the norm.
FDA Consequence:
Unreported deviations, buried quality signals, and missed opportunities for early intervention. Inspectors see this as a breakdown in quality oversight and trust.
TEACM Solution:
Under Coach and Mentor, we help build a culture of psychological safety. Through facilitated workshops and leadership modeling, employees learn that raising concerns is not only accepted—it’s expected. Silence is replaced by structured dialogue and responsive action.
- Passive Training Programs
The Risk:
Training becomes a checkbox. Content is pushed out with little engagement, retention isn’t assessed, and training outcomes are assumed—not verified.
FDA Consequence:
Operators and staff can’t explain their tasks during interviews, leading to observations related to inadequate training or failure to follow procedures.
TEACM Solution:
Train and Educate go hand-in-hand to ensure learning is layered and reinforced. We implement active learning strategies—scenario-based simulations, role play, teach-back techniques—and follow with competency evaluations that ensure the learning sticks.
- Leadership Blind Spots
The Risk:
Executives and senior managers make decisions based on reports and dashboards—but rarely interact with the front line in meaningful ways.
FDA Consequence:
Systemic issues—like rushed investigations or under-resourced teams—are overlooked until FDA inspectors uncover them. Leadership appears disconnected from the quality culture.
TEACM Solution:
Through Audit and Mentor, we bridge this gap. Our cultural assessments provide visibility into daily behaviors and risk areas leadership often misses. Then we mentor leadership teams on how to engage with floor-level realities and set expectations that align with compliance goals.
- Tolerance for Workarounds
The Risk:
People “get creative” when systems are too rigid or when time is short. Workarounds become normalized. Informal processes take root without oversight.
FDA Consequence:
Inconsistent execution, undocumented changes, and ultimately—noncompliance. FDA views this as a lack of control and failure to enforce procedures.
TEACM Solution:
Audit catches where workarounds are creeping in. Coach helps teams explore why they felt they had to bypass the system. Then we train and educate staff to develop better practices that are both compliant and practical. The goal: empower improvement without sacrificing oversight.
- Compliance Fatigue
The Risk:
When everything is urgent, nothing is sustainable. Teams burn out, SOPs are followed mechanically, and deviations start to feel like background noise.
FDA Consequence:
Documentation errors, missed details, and a noticeable drop in GMP discipline. FDA inspectors recognize this as a cultural breakdown in ownership and accountability.
TEACM Solution:
Our Mentor and Coach approach helps re-energize teams by reconnecting them to the mission: patient safety. We introduce rotational engagement strategies, reinforce recognition of proactive behaviors, and help managers reframe compliance as value-driven—not just mandatory.
TEACM: Making Culture Measurable
With the TEACM Method, culture becomes something you can train, monitor, and develop—just like any other part of your compliance program.
Here’s how it works:
- Train – Deliver structured, skills-based instruction that’s job-relevant and performance-focused.
- Educate – Build deeper understanding of why compliance matters through context, case studies, and cross-functional awareness.
- Audit – Proactively assess systems, behaviors, and outcomes to find gaps before FDA does.
- Coach – Support behavior change through targeted, in-the-moment guidance and positive reinforcement.
- Mentor – Develop long-term culture by investing in leaders at every level to model compliance excellence.
Final Thought
Culture is never neutral. It’s either pulling you toward compliance—or pushing you toward your next observation.
If your team is technically competent but behaviorally inconsistent, the issue isn’t knowledge—it’s culture. And that’s where TEACM gives you the tools to rebuild, retrain, and reengage your workforce.
Let’s talk about how we can apply TEACM at your site to prevent findings, increase confidence, and build a culture FDA respects.
www.compliance-insight.com
About the Author
Troy Fugate is Vice President at Compliance Insight, with over 30 years of expertise in pharmaceutical and biotechnology compliance. He is a respected global leader in GMP workforce development and quality system maturity.