FDA inspections are never just routine. They’re a signal of what regulators are watching, where emerging risks lie, and how well your company measures up to evolving expectations. Every inspection is a data point in a much larger trend, and paying attention to the patterns can make the difference between a smooth inspection and a crisis.
One investigator whose work has stood out in recent years is Brittany McCracken. Her inspection record reflects the FDA’s current priorities and offers valuable lessons for pharmaceutical and biotech teams looking to stay ahead of enforcement.
Here’s what her track record tells us, why it matters, and how your quality and regulatory teams can use these insights to prepare smarter.
About Brittany McCracken
Brittany D. McCracken is a U.S. FDA investigator who has conducted more than a dozen inspections in the past two years, largely across pharmaceutical, biotech, and medical device manufacturers. According to publicly available data, she’s already carried out 13 inspections, issuing 8 FDA Form 483s, and has yet to escalate findings to formal Warning Letters.
For compliance teams, this matters. The Brittany McCracken FDA inspection record reflects the agency’s current posture: thorough, risk-based scrutiny designed to help companies correct issues early, with little patience for repeat or systemic failures.
What Her Inspection Record Reveals
McCracken’s inspection history provides a snapshot of how FDA enforcement is shifting.
- More Inspections, Shorter Intervals
McCracken has accelerated her pace, with more than 60% of her inspections taking place in just the last 12 months. This reflects the FDA’s post-pandemic push to clear backlogs, increase oversight, and reassert its on-site presence.
What this means for you: Facilities can expect less notice, tighter schedules, and little room for delay. The days of long gaps between inspections are over — so your systems need to be inspection-ready at all times.
- Focus on Mid-Sized and Innovative Firms
McCracken’s recent site visits have targeted a mix of companies, including:
- Biotech firms like UCP Bioscience and Imedrix
- Medtech manufacturers such as Tivic Healthcare and Echopixel
- Specialty contract manufacturers such as ALOM Technologies and Samax Precision
These are not giant legacy players; they’re high-growth, often innovative firms where quality systems may lag behind rapid development.
Lesson: If you’re in a growth stage, don’t assume the FDA is too focused on larger companies to notice you. In fact, being small or innovative can put you in the spotlight, precisely because inspectors see higher risk in fast-moving environments.
- Form 483s Are Common (and Meaningful)
More than 60% of McCracken’s inspections have resulted in FDA Form 483s. While none have escalated to Warning Letters ( yet), this shows that even companies with otherwise strong reputations are struggling to meet the FDA’s expectations fully.
A Form 483 is not just a piece of paper. It’s a clear signal that your systems need immediate attention. And it’s a test of how well you can respond under pressure.
Takeaway: Don’t treat a 483 like a minor inconvenience. Use it as a roadmap to fix systemic issues before they escalate into something much worse.
Key Trends Emerging From Her Work
Beyond the numbers, McCracken’s inspections point to a few specific areas of regulatory concern that pharma and biotech teams should take seriously.
Trend 1: Heightened Scrutiny of Documentation Integrity
Several of McCracken’s observations have involved documentation issues: incomplete batch records, missing or inconsistent change controls, and poorly documented CAPAs.
Weak documentation is one of the fastest ways to undermine inspector confidence. If you can’t demonstrate control on paper, inspectors will assume you don’t have control in practice.
Action: Conduct pre-inspection audits with a focus on documentation. Look for gaps, inconsistencies, and missing signatures before an inspector does.
Trend 2: Supplier and Outsourced Operations Under the Microscope
McCracken has made a point of inspecting contract manufacturers and component suppliers, a trend that reflects the FDA’s increased emphasis on supply chain integrity.
You’re responsible for the compliance of your suppliers, no matter how good your internal processes are.
Action: Treat supplier audits as seriously as your own. Document qualifications, risk assessments, corrective actions, and ongoing monitoring for every vendor.
Trend 3: Proactive, Not Punitive
So far, McCracken hasn’t escalated findings to Warning Letters. This suggests an FDA philosophy that prioritizes early intervention and gives companies a chance to self-correct, provided they act quickly and thoroughly.
Your 483 response is your chance to show the FDA you take findings seriously and can be trusted to fix them without further prompting.
Action: Draft a clear, evidence-backed response, address each observation in detail, and implement preventive measures to avoid recurrence.
What Pharma Regulatory Teams Should Do Right Now
If McCracken, or any other inspector, showed up at your site tomorrow, would you be ready? Here’s how to make sure you are.
- Run Internal Mock Inspections
Use publicly available data, including investigator profiles like McCracken’s, to simulate realistic FDA scenarios. Focus on the areas she and her peers most commonly flag, such as documentation gaps, supplier oversight, and CAPA effectiveness.
- Address Known Weak Points
Don’t wait for the FDA to tell you what you already suspect. Cross-reference 483 trends in your industry and fix them now. If you manufacture sterile injectables, for example, make sure environmental monitoring and aseptic controls are bulletproof.
- Strengthen Supplier Controls
Apply the same rigor to your supply chain as you do to your internal operations. Document everything, from qualification audits to ongoing monitoring, and make sure your suppliers understand and meet your quality expectations.
- Plan Your 483 Response Strategy
Assign clear ownership of each potential observation ahead of time. Draft response templates, define escalation paths, and train your team on how to communicate with the FDA under pressure. Don’t improvise; plan.
Closing Thoughts
Brittany McCracken’s FDA inspection record is a case study in how the FDA operates today: data-driven, risk-focused, and firm but fair. The companies that do well aren’t the ones that get lucky. They’re the ones that treat every day like inspection day, embedding quality and compliance into every level of their operations.
By studying individual investigator patterns, addressing vulnerabilities proactively, and building a culture of continuous improvement, you can turn every inspection into an opportunity to improve your processes, protect your patients, and strengthen your business.
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Luys Parker