If you’re getting ready for an FDA inspection and see the name Kimberly Schultz assigned to your site, it’s worth paying attention. Every FDA investigator has their approach, and Schultz is known for being detail-focused, especially when it comes to quality systems and documentation.
Knowing what she typically looks for can help you avoid surprises during the audit. By reviewing past Kimberly Schultz FDA inspections, you can spot patterns, strengthen weak areas, and guide your team with confidence.
In this blog, we’ll break down the top findings from Schultz’s inspections and give you practical steps to prepare. Whether it’s CAPAs, validation, or data integrity, you’ll walk away with a clearer picture of what matters and how to stay ahead.
What You Should Know About Kimberly Schultz’s Inspection Style
Kimberly Schultz is a seasoned FDA investigator who has conducted dozens of inspections across pharmaceutical and medical device facilities. Her audits often cover manufacturers handling sterile products, combination products, and OTC drugs.
She’s especially active in regions with high regulatory activity, meaning if your site falls within her territory, there’s a good chance her name might appear on your next inspection notice.
What sets Schultz apart is her thoroughness. She takes a systems-based approach, often looking at how different parts of your quality program work together. If one area shows signs of weakness, like inconsistent batch records or incomplete CAPA investigations, she’s likely to follow that thread through your entire operation.
The Most Common Issues Kimberly Schultz Flags During FDA Inspections
When it comes to Form 483 observations, Kimberly Schultz tends to focus on key areas that often reflect how well your quality systems are functioning in the real world. Her findings show a pattern; she’s not just checking boxes; she’s looking for signals that something bigger might be slipping through the cracks.
Here are the most frequent issues she flags, and what they tell us:
1. Inadequate Investigations
Schultz often cites companies for incomplete or poorly documented investigations. Whether it’s a deviation, OOS result, or customer complaint, she expects clear root cause analysis, not vague explanations or repeated “human error” conclusions.
What to do:
- Review recent investigations and CAPAs, are they tied to evidence and verified?
- Make sure effectiveness checks are documented and realistic.
2. Missing or Inconsistent Batch Records
Batch records that are incomplete, illegible, or not reviewed properly are a common theme in her observations. She tends to dig into the details, especially when there are corrections or discrepancies.
What to do:
- Audit recent batch records for accuracy and completeness.
- Ensure corrections follow your SOP and don’t suggest data manipulation.
3. Validation Gaps
Schultz doesn’t just look for whether validation was done; she looks at how it was done. If your process validation, cleaning validation, or equipment qualification is poorly justified or missing key parameters, expect questions.
What to do:
- Cross-check your validation protocols against current FDA expectations.
- Make sure revalidation is triggered when needed (e.g., process changes, deviations).
4. Weak Data Integrity Controls
She has also cited firms for lapses in data integrity, like shared login credentials, lack of audit trails, or uncontrolled spreadsheet use.
What to do:
- Review user access logs and audit trail settings on critical systems.
- Ensure that backup, version control, and change tracking are in place.
5. Gaps in Training Documentation
Training records that are missing, outdated, or don’t match the employee’s current role are a red flag. Schultz often checks whether operators and analysts are trained on the latest SOP versions.
What to do:
- Verify that training logs are up to date and aligned with each employee’s job function.
- Document retraining after SOP updates or deviations.
How to Use These Insights to Strengthen Your Quality Systems
Now that you know the areas Kimberly Schultz focuses on, the next step is using that knowledge to get ahead, before an FDA inspection is even on your calendar.
Here’s how to apply these findings in a practical, internal setting:
Conduct a Mock Audit Focused on Her Top 483s
Use Schultz’s most frequently cited issues, like inadequate investigations and validation gaps, as the backbone of your internal audit plan. Instead of trying to cover everything at once, go deep where she tends to go deep.
Pro tip: Simulate a walkthrough with Schultz’s inspection style in mind. Can your team confidently explain why certain CAPAs were closed? Can they show validation reports without scrambling?
Cross-Check SOPs and Actual Practice
It’s not enough to have SOPs in place. Schultz often flags gaps between documented procedures and what’s actually happening on the floor. Pay special attention to areas like batch record review, data integrity, and training compliance.
What to check:
- Do operators follow SOPs during real-time work?
- Are deviations handled consistently, not selectively?
Tighten Your Documentation Trail
Schultz is known for requesting documents across systems to see how well they connect. For example, she might look at how a complaint investigation links to CAPA, and whether that CAPA impacted any product batches or validations.
How to prepare:
- Map your document flow across systems (e.g., complaint → investigation → CAPA → training update)
- Prepare traceability logs that show end-to-end control
Involve QA Early and Often
One of the biggest red flags is when quality assurance appears reactive instead of proactive. If QA is only visible during audits, that’s a problem. Schultz often evaluates how integrated QA is into daily decision-making.
To improve:
- Document QA interventions across change control, deviations, and supplier oversight
- Make sure QA has real-time visibility, not just post-review authority
How to Use Inspector Intelligence to Reduce Audit Risk
Being prepared for an FDA inspection means more than just checking your SOPs and training logs. The most forward-thinking compliance teams are using inspector-specific data to tailor their audit readiness, and Kimberly Schultz is a great example of why that matters.
Platforms like Atlas Compliance make this possible by giving you real-time access to FDA inspection histories, trends, and observation patterns tied to individual investigators.
Why It Matters
Kimberly Schultz’s focus on systems like CAPA, validation, and batch records isn’t random; it’s based on her inspection history. If you know these are her high-priority areas, you can prepare accordingly rather than relying on guesswork.
With the right data, you can:
- Prioritize internal audits based on actual enforcement history
- Train your team using real examples from Schultz’s past 483s
- Align your SOP reviews and QA walkthroughs with her known focus areas
Conclusion
Kimberly Schultz’s inspection history shows a clear focus on quality system fundamentals, from investigations and validation to data integrity and training compliance. Her audits remind us that it’s not just about having documentation in place, it’s about proving your systems work in practice.
If you want to stay ahead of these risk areas, tools like Atlas Compliance can help. By turning FDA inspection data into actionable insights, the platform empowers you to prepare smarter for site visits, especially when you know your inspector’s name.
Explore past findings, align your audit strategy, and gain clarity on what to expect when Kimberly Schultz is leading the inspection.
Schedule a demo today to see how Atlas Compliance can support your team’s inspection readiness, from insight to execution.
