FDA inspections are part of life in the pharmaceutical, biotech, and medical device industries. Yet even the most experienced QA and Regulatory teams can find themselves blindsided when an inspector uncovers gaps they didn’t know existed.
Rosanna Goodrich, a respected expert in life sciences compliance, has seen it all — from well-prepared teams sailing through to others scrambling in the face of 483s and warning letters. Drawing on her expertise, this post lays out her most impactful recommendations for FDA inspection readiness, tuned for the realities of today’s enforcement climate. Let’s break it down.
Why FDA Inspection Readiness is More Critical Than Ever
The stakes are higher now than they were even a few years ago. Post-pandemic, the FDA has been catching up on its inspection backlog, while also tightening its expectations. There’s more attention to data integrity, more pressure for supply chain transparency, and a bigger emphasis on whether your company truly lives its quality culture, not just documents it.
Inspections themselves have evolved, too. Many are hybrid, with remote document reviews followed by onsite visits. Teams that rely on “business as usual” often find themselves underprepared for these new dynamics.
Here’s a data point to keep in mind: in fiscal year 2023, the FDA issued over 4,400 Form 483s, a significant proportion for failures that could have been prevented with better internal controls — incomplete CAPAs, outdated SOPs, undocumented decisions, and poor training records.
The lesson? Readiness isn’t just about the day the inspector shows up. It’s about building confidence and capability into your daily operations so you’re never caught flat-footed.
Understand What’s Changed: New FDA Priorities in 2025 and Beyond
Rosanna Goodrich urges companies to keep an eye on the big trends shaping enforcement. Three themes keep coming up in her recent inspections:
- Data integrity: Inspectors dig deeper into electronic records and audit trails, looking for backdating, inconsistencies, and missing metadata.
- Supply chain transparency: They now expect documentation that shows you know exactly where materials are coming from and how risks are mitigated.
- Quality culture: It’s no longer enough to just have SOPs on paper. Inspectors interview staff to see if a real culture of compliance exists.
For example, in one recent inspection of a mid-sized biotech, employees were unclear about their responsibilities during deviations, which led to a Form 483 even though the paperwork itself was technically compliant.
How to Prepare for an FDA Inspection: Step by Step
Step 1: Start with Your Quality Culture
This is where Goodrich starts every conversation. Inspectors can quickly tell if your quality mindset is just performative or real.
Red flags she often sees:
- Employees can’t clearly explain their roles during an audit.
- SOPs are outdated but still in use.
- CAPAs are written just to close findings quickly, without fixing underlying problems.
Her recommendation? Conduct regular, realistic mock inspections that test not just documentation, but also staff behavior and responsiveness. Rotate who leads these, or bring in outside auditors to avoid blind spots.
Step 2: Know Your Inspector
One of Goodrich’s most underutilized tips is to learn about the inspector in advance. Different inspectors emphasize different things — some drill into sterile processing, others into supply chain controls.
With modern tools like Atlas Compliance, you can access detailed profiles of individual FDA inspectors, learn their historical focus areas, and even see trends by region or therapeutic area.
For example, Atlas data shows that inspectors in some FDA districts cite data integrity failures at nearly twice the national rate. If you know your assigned inspector has a history of issuing 483s for missing audit trails, you can focus your pre-inspection prep accordingly.
Step 3: Audit Yourself — But Make It Count
Too many internal audits fail to uncover real risks because they just go through the motions.
A stronger approach includes:
- Challenging assumptions: Are records truly contemporaneous? Are suppliers fully qualified? Are CAPAs verified?
- Simulating real-life scenarios, where auditors ask for documents you don’t normally pull.
- Using independent third-party auditors occasionally to bring fresh eyes and objective feedback.
It’s always better to uncover and fix a problem yourself than to let the FDA find it first.
Step 4: Get Documentation Right
Don’t confuse volume with quality. Rosanna Goodrich has flagged companies that handed over mountains of paperwork, only for her to find key gaps.
What inspectors really care about:
- ALCOA+ principles: Are records Attributable, Legible, Contemporaneous, Original, Accurate, and more?
- Electronic records that are tamper-proof, validated, and backed up.
- Documentation that explains actions clearly, with no ambiguous gaps or missing timestamps.
Here’s a real-world example: in a 2023 inspection, a device manufacturer received a warning letter because their CAPA records lacked proper timestamps, even though all actions had been taken on time.
Step 5: Prepare Your People
Your frontline employees are often the first, and most important, impression an inspector has.
Goodrich advises companies to:
- Train everyone to keep answers factual, concise, and within their knowledge.
- Designate a single point of contact to handle requests and communicate with the inspector.
- Run practice interviews during mock audits to build confidence and consistency.
One memorable situation involved a line worker speculating about the cause of an out-of-spec batch. That guess prompted the inspector to dig deeper and escalate findings, resulting in a 483. The right answer? A simple: “I’ll check with QA on that and get back to you.”
Step 6: Use Technology to Stay Ahead
Finally, don’t underestimate the value of technology. Keeping pace with FDA expectations and trends manually is nearly impossible at scale. Platforms like Atlas Compliance can help you:
- Get real-time alerts about enforcement trends and inspection outcomes in your sector.
- Review inspector profiles and benchmark your facility against others.
- Use AI-driven risk scoring to prioritize your efforts where they’ll have the biggest impact.
The Bottom Line
Preparing for an FDA inspection isn’t just about passing the next one; it’s about creating a sustainable system and culture that can stand up to scrutiny every day.
By understanding current FDA priorities, auditing yourself with rigor, training your people effectively, and investing in smart tools to monitor risks, you can stay multiple steps ahead of enforcement.
Rosanna Goodrich’s key message is clear: inspections don’t have to be adversarial or stressful if you’ve built a truly compliant operation. They can even be an opportunity to validate and showcase your commitment to quality. Don’t wait for the inspector to show you where you’re vulnerable. Start strengthening your systems today.
