Every FDA investigator brings their own style, focus, and expectations to an inspection, and that can have a big impact on your outcome. Deanna Bousalis is one of those names that come up often in the context of FDA inspections, especially in the pharmaceutical and biotech industries.
If your facility is on her schedule, it pays to understand what she tends to look for, the kinds of issues she’s flagged in the past, and how her approach might shape the inspection process.
This article dives into Deanna Bousalis FDA inspection patterns, highlights key lessons from her previous findings, and offers practical steps you can take to prepare your team and avoid common mistakes.
Who Is Deanna Bousalis?
Deanna Bousalis is a career FDA investigator with significant experience inspecting pharmaceutical and biotech facilities. Over the years, she has conducted inspections for the U.S. Food and Drug Administration across multiple states, focusing heavily on cGMP compliance and sterile manufacturing environments.
Her inspection history spans a wide variety of operations — from small-scale clinical manufacturing facilities to large commercial plants. This breadth of experience makes her a thorough and well-informed inspector who’s hard to catch off guard.
Many QA teams who’ve hosted her inspections have remarked on her ability to identify not just technical nonconformances but also procedural or systemic weaknesses that others might overlook.
Inspection Trends in Her Cases
When we analyzed inspection records tied to Deanna Bousalis, some clear patterns emerged. Her findings align closely with current FDA priorities but also reflect her own style and thoroughness.
1. Data Integrity and Recordkeeping
A large proportion of her Form 483 observations are related to data integrity lapses. These include:
- Batch records with incomplete or inconsistent entries
- Electronic audit trails are missing key events
- Logbooks are maintained inconsistently or retroactively
- Evidence of uncontrolled spreadsheets or hybrid paper–electronic processes
Her observations often highlight how poor recordkeeping undermines the credibility of the entire quality system, a message the FDA has been stressing for years.
2. CAPA Weaknesses
She has flagged inadequate corrective and preventive action systems, including:
- Investigations that don’t identify a true root cause
- CAPAs closed without evidence of effectiveness
- Repeated deviations with no systemic fix
This signals her expectation that firms not only react to issues but also build resilient systems that prevent recurrence.
3. Environmental Controls
In sterile manufacturing settings, she has repeatedly found:
- Unqualified cleanrooms in use
- Inadequate environmental monitoring frequencies
- Failure to trend and respond to microbial or particulate counts
- Operators deviating from aseptic technique without documented retraining
These findings underscore her focus on patient risk, contamination control being one of the most critical elements of GMP.
4. Supplier Quality Oversight
In several cases, she noted:
- Lack of initial qualification audits for vendors supplying critical materials
- Missing or outdated supplier agreements
- No evidence of ongoing supplier performance monitoring
These issues often reflect a company’s failure to view suppliers as an integral part of their own quality system.
Her findings tend to include detailed narratives and examples from the facility itself, rather than generic citations, which shows her commitment to providing actionable feedback.
What Sets Her Approach Apart?
Many QA teams describe Deanna Bousalis as thorough but fair, with a calm and methodical inspection style. Unlike some inspectors who race through checklists, she spends more time verifying how processes actually work.
Here are a few traits that stand out:
- Process Over Paper: She doesn’t stop at reviewing SOPs and records. She walks through procedures step by step with operators to see if what’s written matches what’s done.
- System Focus: Rather than fixating on isolated errors, she evaluates whether the overarching quality system is designed to prevent those errors.
- Depth Over Breadth: She might spend an hour in one area of the facility to fully understand it rather than skimming through several departments.
- Direct but Professional: Her observations are clear and well-supported, leaving little ambiguity about what needs improvement.
This is why it’s crucial for companies to not just have documentation ready, but also ensure staff are well-trained and processes are being followed consistently.
Lessons for QA & Compliance Teams
Studying an inspector’s past findings gives you a head start. Here’s what you can do to prepare for an inspection by Deanna Bousalis — or any investigator with a similar style:
- Run mock inspections focused on data integrity controls, particularly around batch record review, audit trails, and logbooks.
- Strengthen your CAPA process: Audit your own investigations. Are they superficial? Do they identify systemic causes? Are effectiveness checks documented?
- Audit your environmental monitoring program: Verify that cleanrooms are qualified, monitoring frequencies are appropriate, alert/action limits are justified, and trends are being reviewed and acted upon.
- Review your supplier qualification files: Ensure that initial audits, contracts, risk assessments, and ongoing monitoring are documented and current.
- Train operators on SOP adherence: Spot-check by observing actual procedures and asking staff to explain them. Are they following the SOP as written? Do they understand why each step matters?
Why Investigator Patterns Are Just the Beginning
It’s worth remembering that inspectors rotate assignments, and their own priorities evolve over time as regulations, guidance, and enforcement trends shift.
This means you shouldn’t rely solely on anecdotal experience. You need a systematic way to track patterns across inspectors and stay current with real-world inspection data. That’s where a platform like Atlas Compliance comes in.
How Atlas Compliance Helps You Prepare
Atlas Compliance gives you a clear advantage by analyzing inspection data and building detailed FDA investigator profiles. You’ll know their history, common findings, and focus areas before they even step on site.
With Atlas, you can:
- Generate a pre-inspection report tailored to your site and the assigned investigator.
- Benchmark your quality system against peers in your sector.
- Use AI-driven Copilot to draft strong 483 responses and prioritize the most impactful improvements.
- Receive alerts when new observations or warning letters appear in your industry.
It turns raw data into actionable intelligence, so you’re always ready, even for an inspection led by Deanna Bousalis.
Conclusion
Understanding the regulations is only half the battle. Understanding the people enforcing them is what gives you the edge. Deanna Bousalis is an experienced FDA investigator with a reputation for fairness, attention to detail, and a focus on systems rather than isolated paperwork errors. Facilities she inspects often cite her ability to identify not just gaps but also opportunities to strengthen their quality culture.
By studying her inspection patterns, addressing vulnerabilities proactively, and training your team to demonstrate compliance both on paper and in practice, you can avoid preventable pitfalls.
