Inspection readiness has always been a cornerstone of GMP compliance, but in 2025 the landscape feels different.
FDA inspections are happening with less predictability, often led by inspectors with a wide range of backgrounds and experience levels. That variability can mean more 483s for issues that might not have been cited in the past, more scrutiny of documentation, and higher expectations for transparency across quality systems.
To explore how companies can sustain readiness under these conditions, The FDA Group’s Nick Capman sat down with Jeff Brenneman, Vice President of Global Operations Quality at Alora Pharmaceuticals. Jeff brings more than 25 years of experience leading quality and operations across branded, generic, and OTC manufacturing, including site and global leadership roles at Osmotica, Oxford Pharmaceuticals, Par/Qualitest, and now Alora.
What follows is a detailed look at Jeff’s advice, expanded with examples and practical insights drawn from The FDA Group’s own experience supporting inspection readiness across hundreds of FDA-regulated sites.
Jeff is clear: companies can no longer afford to treat inspections as isolated events. Staffing changes at FDA mean more variability in inspector expertise and style. A seasoned investigator might weigh context before citing an observation, while a less experienced one may cite everything that isn’t perfectly clear.
What this means for industry:
We've seen clients blindsided when documentation that once “passed” suddenly triggered a 483. The difference wasn’t the company’s performance—it was the inspector’s discretion. Organizations that adopt the mindset of “always inspection-ready” adapt faster, avoid panic responses, and demonstrate credibility no matter who walks in.
Jeff emphasizes the importance of documentation that can be understood by anyone—not just experts steeped in your products or acronyms.
“The way you write a report matters. If an inspector can’t follow the context and logic, it raises questions that could have been avoided.”
A few tips here:
We recently helped a client reduce inspection findings by reformatting investigation templates. The new template forced authors to state the problem, context, data, and conclusion in a simple sequence. FDA investigators later remarked on the clarity and transparency—a positive signal that built trust.
In Jeff’s words, a robust system isn’t one with the most layers of checks and documentation. It’s one that is clear, consistent, and efficient.
That means:
Complex, overlapping systems may look “thorough,” but in reality they create risk: staff confusion, inconsistent execution, and longer review times.
When we support clients in QMS remediation, the most common problem isn’t missing procedures—it’s too many. Simplifying procedures into unified global standards, then tailoring where necessary, creates a leaner system that still satisfies regulators.
Jeff makes a critical point: inspection readiness isn’t about ticking off GMP boxes. It’s about protecting both compliance and business sustainability.
“You can be compliant all day long, but if you’re not profitable, no one has a job. And if you’re profitable but not compliant, you won’t be in business for long.”
The lessons here are pretty straightforward but often overlooked:
We've sometimes seen companies reduce deviation investigation times by over 40% by focusing on root cause and systemic fixes rather than exhaustive “box-ticking.” The result: fewer repeat issues, faster batch release, and lower costs—all while improving compliance outcomes.
Despite all the talk about new technology, Jeff stresses that the fundamentals remain critical.
We often uncover data integrity gaps during mock inspections, such as audit trails not reviewed or backup systems untested. These are preventable findings that can erode confidence quickly in an inspection. Regular internal “stress tests” of systems keep surprises from surfacing when the FDA arrives.
Inspection readiness is not just a system problem—it’s a people problem. Jeff emphasizes culture as the foundation:
When quality is siloed, readiness becomes reactive—teams scramble during inspections because processes aren’t truly owned across the business. When quality is embedded and staff are cross-trained, readiness is ongoing, sustainable, and far less stressful.
Jeff Brenneman’s message is clear: FDA inspections are less predictable, so readiness must become a permanent operating state. That means:
When organizations internalize these principles, inspections shift from anxiety-inducing events to opportunities to showcase maturity, reliability, and trustworthiness.
🎧 Listen to the full conversation with Jeff Brenneman on The Life Science Rundown »
While this guide provides a comprehensive framework for FDA inspection readiness, implementing these practices effectively often requires experienced guidance. The FDA Group offers a suite of specialized services designed to transform your inspection readiness from concept to reality.
Our mock inspections go beyond simple compliance checks. Led by a network of over 250 former FDA personnel, these simulated inspections provide an authentic experience that mirrors what you can expect from actual FDA investigators.
Here's what makes our mock inspections different:
Learn more about our mock inspection services »
Our support extends beyond mock inspections to include:
Don't wait for an FDA investigator to test your readiness. Contact us to discuss how we can help prepare your organization for successful regulatory inspections.
Contact us to:
Submit the form below to express your interest and get the conversation started.