Rosanna Goodrich FDA Investigation Trends: Insights from 10 Audits

FDA inspections aren’t one-size-fits-all. Every investigator walks in with the same regulatory framework, but how they apply it and where they focus vary. That’s why understanding an individual investigator’s patterns can give your compliance team a real advantage.

Rosanna Goodrich is one such FDA investigator whose audits consistently surface key risk areas. Known for her meticulous, evidence-based approach, Goodrich has a track record of pinpointing lapses that others might miss. If your operation sits in one of the industries she audits, pharmaceuticals, sterile injectables, or biologics, knowing what she’s looking for can help you stay a step ahead.

We analyzed 10 of her recent audits to uncover the trends that matter most. Here’s what we learned, and what you can do with those insights to strengthen your inspection readiness.

Who Is Rosanna Goodrich?

Rosanna Goodrich is a seasoned FDA field investigator, widely recognized for her meticulous audits of pharmaceutical and biologics manufacturing sites. The Rosanna Goodrich FDA inspection record shows a consistent focus on high-risk areas like aseptic processing, contract manufacturing, and sterile injectables, sectors where compliance lapses can have serious consequences.

She’s often mentioned in FDA Warning Letters and industry discussions for pinpointing recurring gaps in quality systems. If your facility falls within her typical audit scope, understanding her approach and priorities is crucial to being inspection-ready.

How We Analyzed Her Inspections

We reviewed ten audits conducted by Goodrich between 2022 and 2024, using data aggregated from FDA Form 483s, Establishment Inspection Reports (EIRs), and Warning Letters. The sites audited ranged from midsize generics manufacturers to large biologics producers, all based in the United States.

For each inspection, we categorized the findings into standard FDA citation themes: data integrity, environmental controls, CAPA systems, supplier oversight, and employee training.

This structured analysis revealed consistent focus areas and notable outliers worth paying attention to.

5 Key Trends in Rosanna Goodrich’s Findings

Here are the 5 main trends in Rosanna Goodrich’s FDA findings:

1. Increased Scrutiny on Data Integrity

Data integrity issues were cited in the majority of her audits, making it her most consistent area of focus.

Findings included:

• Incomplete or altered batch records
• Missing audit trails in electronic systems
• Lack of controls over who could modify critical data
• Failure to follow ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and more)

What this means: Teams need to do more than just collect data; you need to prove it’s accurate, secure, and tamper-proof. Validate your electronic systems, lock down access, and routinely audit for vulnerabilities.

2. Environmental Monitoring Shortcomings

Goodrich routinely flagged weaknesses in EM programs, particularly in cleanroom and aseptic processing areas.

Examples include:

• Poor trending of microbial and particle count data
• Sampling at inappropriate or undocumented control points
• Lack of documented rationale for monitoring locations
• Failure to act on recurring contamination trends

In one case, a sterile injectables plant failed to investigate repeated excursions over six months, which Goodrich noted as a sign of systemic quality oversight failure.

Action step: Your EM program needs to go beyond daily checks. Ensure you trend data over time, investigate deviations thoroughly, and adjust sampling plans as needed to reflect real risk.

3. Supplier Qualification and Oversight Gaps

Supplier oversight emerged as another recurring weakness. Goodrich’s audits found:

• Missing or outdated supplier audit documentation
• No ongoing evaluation of supplier performance
• Inadequate evidence that suppliers implemented effective CAPAs when required

This reinforces the FDA’s message that manufacturers are ultimately responsible for the quality of outsourced activities, even when performed by “qualified” vendors.

What you should do:

• Implement a formal supplier qualification and monitoring program.
• Document supplier audits, findings, and follow-up actions.
• Include suppliers in your facility’s risk assessments.

4. Employee Training Documentation Issues

Goodrich consistently zeroes in on employee training — not just whether training has occurred, but whether it’s been documented, verified, and updated.

Common findings:

• Outdated SOP training records
• Missing evidence of retraining after procedure updates
• No verification that employees understood or retained the training

Pro tip: Training is only defensible if it’s documented. Maintain complete records, include assessments to measure effectiveness, and schedule periodic retraining where appropriate.

5. Superficial CAPAs and Weak Root Cause Analyses

Finally, many of Goodrich’s audits cited CAPAs that didn’t go deep enough or failed to address systemic issues.

Examples include:

• CAPAs closed before verifying effectiveness
• Investigations that stopped at symptoms rather than root causes
• Repeated findings in the same area despite “corrective” actions

Takeaway: Treat CAPAs as a chance to strengthen your systems, not just to check a box. Ensure investigations identify true root causes, corrective actions address them fully, and preventive measures are put in place to avoid recurrence.

How Her Approach Compares to Other FDA Inspectors

When benchmarked against FDA averages (using Atlas Compliance inspector analytics), Goodrich stands out for citing data integrity and environmental monitoring issues more often than her peers, while being about average on CAPA-related findings.

This indicates a strong focus on systemic risks that can directly compromise product quality, particularly in sterile and high-risk environments. Companies that don’t take these areas seriously are more likely to be cited under her scrutiny.

What QA and Compliance Teams Should Do Next

Here’s the thing: these patterns aren’t just trivia. They’re signals you can use to prepare better if your facility is inspected by Goodrich or any investigator with similar priorities.

Proactive Steps:

• Perform internal audits on her key focus areas. Use mock inspections to stress-test data integrity, EM, and CAPA systems.
• Update and trend your EM results. Don’t just collect, analyze, and act.
• Audit your vendors rigorously. Keep complete records of supplier qualifications and oversight.
• Verify training programs. Ensure records are up to date and include proof of effectiveness.
• Treat CAPAs seriously. Go deep on the root cause and verify effectiveness before closure.

By leveraging inspector-specific insights, you can align your compliance program with what the FDA (and this investigator) are most likely to scrutinize.

Closing Thoughts

Every FDA investigator brings their own lens to the job. Rosanna Goodrich’s consistent focus on data integrity, environmental monitoring, supplier oversight, and training highlights some of the most common and most critical weaknesses in the industry.

By studying her patterns and preparing accordingly, you can avoid preventable citations, demonstrate a strong quality culture, and build trust with regulators.

Don’t wait for an inspection notice to find your gaps. Platforms like Atlas Compliance make it easy to track inspector patterns, benchmark your risk, and proactively strengthen your compliance posture.