FDA Investigations by Conner Mann

An FDA inspection is never routine, especially when it’s led by someone like Conner Mann. Known within the industry for his sharp attention to detail, Mann has built a reputation for identifying gaps and weaknesses that others might overlook. His inspections don’t stop at surface-level compliance. Instead, they probe deeper into systemic issues, repeat findings, and how effectively companies have addressed prior citations.

For food, drug, and device manufacturers, understanding what investigators like Mann tend to prioritize isn’t just helpful — it’s essential for avoiding costly disruptions and maintaining trust with regulators and customers alike.

This article outlines the patterns that stand out in Mann’s inspections, the most common pitfalls he identifies, and the steps your team can take to prepare with confidence.

Why Knowing the Inspector Matters

Not all FDA investigators approach inspections the same way. While all follow agency policy, each brings their own experience, priorities, and interpretation of the regulations.

Conner Mann is recognized for his thoroughness, especially around data integrity, environmental controls, and repeat findings. If you’re in his jurisdiction or know he’s assigned to your facility, you have an opportunity to prepare more effectively by focusing on the issues he’s most likely to scrutinize.

Being ready for him isn’t about gaming the system; it’s about building stronger, more resilient compliance practices that stand up to any inspection.

Who Is Conner Mann, and What Does He Inspect?

Conner Mann is an FDA field investigator with extensive experience in the human and animal food, pharmaceutical, and medical device sectors, with a focus on facilities in the Eastern and Midwest regions of the United States.

His assignments have spanned both routine surveillance inspections and for-cause investigations, often at facilities with a history of prior compliance issues or at high-risk manufacturing sites like sterile drug operations and dietary supplement producers.

Over the past two years alone, he has signed off on several notable Form 483s, highlighting issues such as:

• Inadequate contamination control in sterile manufacturing

• Systemic failures in supplier qualification at a dietary supplement plant

• Data integrity breakdowns in laboratory information management systems (LIMS) at a pharmaceutical QC lab

These high-profile cases illustrate his willingness to dig into systemic gaps, not just isolated errors.

Top Issues Conner Mann Has Cited: FDA Records Tell the Story

An analysis of FDA inspection records tied to Mann over the past 24 months reveals a clear pattern of findings. Below are the most common observations he’s issued:

Manufacturers frequently fail to demonstrate, with data, that their cleaning methods effectively prevent cross-contamination between products. In some cases, firms lacked any scientifically sound rationale for their cleaning limits.

Recurring problems include missing audit trails, backdated records, uncontrolled spreadsheets, or failure to restrict access to electronic data systems. For Mann, clean documentation isn’t enough; he expects controls that prevent manipulation or loss of critical data.

He often cites firms for closing corrective and preventive actions without adequately addressing root causes or documenting effectiveness checks. “Quick fixes” don’t hold up under his scrutiny.

Another frequent finding: suppliers approved without documented, risk-based evaluations or ongoing monitoring. In some instances, outdated or missing contracts compounded the issue.

Mann has flagged insufficient trending of environmental monitoring results, failure to respond effectively to excursions, or inadequate sampling plans in critical cleanroom environments.

These aren’t just theoretical risks; they’re documented patterns. Knowing this, you can audit your own systems through the same lens.

What Sets Conner Mann Apart: Patterns and Priorities

Many QA and regulatory managers we’ve spoken with report that inspections led by Conner Mann tend to be more rigorous and less forgiving of superficial fixes. Three things stand out:

• Focus on repeat issues: Mann is known for reviewing a facility’s prior 483s, internal audits, and even customer complaints. He asks pointed questions about how earlier findings were addressed and whether they’ve recurred.

• Evidence over policy: Having well-written SOPs won’t impress him unless you can also show evidence they’re being followed and that they actually work. He expects data that demonstrates effectiveness.

• Employee interviews: He doesn’t just talk to management. Mann often interviews line staff to test their knowledge of procedures and their understanding of quality responsibilities.

In short, he looks beyond paperwork to see whether your quality culture actually supports compliance day-to-day, and whether your employees can demonstrate that in practice. 

How Food and Drug Firms Can Prepare Before a Visit

If you know Conner Mann is scheduled to visit, or if you simply want to be ready for inspectors like him, here are specific actions you can take now:

This level of preparation not only reduces your risk of citations but also strengthens your overall compliance posture.

How Atlas Compliance Helps You Stay Ahead

Here’s where Atlas Compliance makes a real difference. Our platform doesn’t just show you FDA trends at a high level; it lets you drill down to inspector-specific data, including patterns like those associated with Conner Mann.

With Atlas, you can:

• See a dashboard of past findings from Conner Mann’s inspections to benchmark your own readiness.

• Get predictive risk scores for your facility compared to similar firms.

• Use our AI Copilot to draft responses to likely questions and guide you through document preparation.

• Receive real-time alerts when inspection patterns shift in your region or sector.

By giving you actionable intelligence and tools, we help you focus your resources where they matter most.

Summing Up

At the end of the day, the FDA's mission is to protect public health, and so is yours. Preparing thoroughly for inspectors like Conner Mann shows regulators, your customers, and your employees that you take that mission seriously.

Understanding his patterns, anticipating his questions, and addressing risks before they become findings makes inspections smoother and less stressful, and strengthens your operations long after the inspection is over. You don’t control who the FDA assigns to inspect you. But you do control how ready you are to meet the challenge.