Patrick Gainer FDA Profile: What Manufacturers Should Expect in Inspections

Patrick E. Gainer is one of the FDA’s most active and experienced field investigators, with a track record spanning more than 180 inspections across the United States and Europe. For manufacturers in the food, cosmetics, dietary supplements, and related sectors, understanding their inspection style and focus areas is helpful. 

Here’s the thing: not all FDA inspectors operate the same way. Each investigator brings their own background, priorities, and way of looking at risk. If your name lands on Gainer’s list, you’re dealing with someone who has seen just about every mistake in the book and who is unlikely to overlook gaps in hygiene, documentation, or process control.

So what exactly does his inspection history tell us? And what can you do today to prepare your facility if he shows up at your door? Let’s break it down.

Who is Patrick E. Gainer?

Patrick Gainer is an experienced FDA investigator with over 180 completed inspections to his name, as of early 2024. He operates primarily in the United States but has also led inspections in Italy, Switzerland, Germany, and Portugal.

His portfolio shows a strong focus on food and cosmetic manufacturing sites, though he’s also inspected dietary supplements and related facilities. If you operate in one of these industries, there’s a fair chance his name could appear on your next inspection report.

For context: his most recent known inspection took place in February 2024. That kind of active cadence signals an inspector who’s deeply engaged with the field — and up to date on the latest regulatory priorities.

Patterns in Patrick Gainer’s Inspections

Understanding his track record can help you anticipate where he’s likely to focus and where your own vulnerabilities might lie.

Facility Types

Gainer has inspected a variety of facilities, but his portfolio consistently includes:

• Food manufacturers and processors
• Cosmetic production sites
• Dietary supplement manufacturing facilities
• Warehouses and distributors for these products

Recent Examples

• Regal Health Food International, Inc. (Chicago): A 10-day inspection in September 2024, resulting in Form 483s citing labeling inconsistencies and poor sanitation documentation.
• American Naturavit, Inc. (Miami): Comprehensive inspection earlier in 2024, with observations around process control gaps and incomplete employee hygiene training records.

Common Outcomes

Gainer’s inspections often result in FDA Form 483 observations. This isn’t unusually high by FDA standards, but it’s enough to signal that facilities he inspects often have room for improvement.

The most common citations in his reports tend to fall into a few familiar categories:

• Mislabeling of products
• Incomplete or inconsistent batch documentation
• Weaknesses in sanitation and hygiene practices
• Lapses in process controls, such as failure to monitor critical parameters

These patterns reflect both the FDA’s current enforcement priorities and Gainer’s own emphasis on clear, defensible records and safe, sanitary operations.

What to Expect During an Inspection

So what’s it like when Patrick Gainer arrives at your facility? Knowing his style can help your team feel more confident and focused.

Before the Visit

• Advance notice: FDA may issue a formal notice when required, but unannounced inspections are common in its portfolio, particularly for food and cosmetics.
• Preparation: Review your most recent inspection outcomes, check that corrective actions were implemented, and align your practices to current FDA expectations.
• Do your homework: Platforms like Atlas Compliance can help you study Gainer’s inspection history and identify the most frequent gaps he cites.

On-Site

Gainer is known for a thorough, methodical approach:

• Inspections can last anywhere from a few days to two weeks, depending on the size and complexity of your facility.
• He tends to review records first, particularly batch records, labeling approvals, sanitation logs, and employee training files.
• He then conducts detailed walkthroughs of your facility, examining production areas, cleanrooms, warehouses, and employee hygiene stations.
• He is likely to interview both management and frontline employees, checking that the people doing the work understand and follow the SOPs.

Common Hot Spots

Expect scrutiny in these areas:

• Labeling and claims: Do your product labels comply with FDA regulations? Are claims substantiated?
• Batch records: Are they complete, contemporaneous, and aligned with actual operations?
• Sanitation and hygiene: Are cleaning schedules followed? Are employees properly trained and documented?
• Traceability: Can you track raw materials and finished goods through your process?

If You Receive a Form 483

If Gainer identifies deficiencies, you’ll likely receive a Form 483 outlining his observations. This isn’t the end of the world, but it is your opportunity to demonstrate your facility’s commitment to fixing problems promptly. Here’s what to do: 

• Stay calm and professional during the closing discussion.
• Document the observations carefully and make sure you understand each one.
• Begin immediate root cause analysis for each cited issue.
• Draft a clear, realistic CAPA plan, with specific owners and timelines.
• Submit your response promptly and follow through on the corrective actions.

Facilities that respond proactively and communicate effectively with the FDA are less likely to see issues escalate into Warning Letters.

Learning From Real Examples

One of the most instructive examples is the September 2024 inspection of Regal Health Food International. Gainer spent 10 days on-site — a strong indication of the depth of his review — and issued 483s that highlighted weaknesses in labeling and sanitation controls.

Takeaway: manufacturers should be ready to demonstrate not just that procedures exist on paper, but that they’re actively followed, documented, and verifiable.

How Inspector Profiling Gives You an Edge

Here’s the thing: not all FDA inspectors emphasize the same things. Inspector profiling — understanding what specific investigators tend to focus on — lets you prioritize the right areas before an inspection even begins.

Atlas Compliance makes that possible by:

• Aggregating Patrick Gainer’s full inspection history
• Summarizing the specific 483 language he’s issued
• Highlighting trends over time in his inspections
• Benchmarking your performance against facilities he’s visited before

And with the AI-powered Inspector Copilot, you can even simulate a Q&A with insights from his past inspections, helping you prep your team for the kinds of questions he’s likely to ask.

Preparing Your Organization

If you operate in food, cosmetics, or dietary supplements, here’s what you can do now to get ready, especially if Gainer could show up at your door:

Immediate Steps

• Review Patrick Gainer’s inspector profile on Atlas
• Audit your labeling and documentation practices
• Refresh sanitation and hygiene training for staff
• Run a mock inspection focused on his typical findings
• Plan a CAPA framework in advance, just in case

Final Thoughts

Understanding the inspector walking into your plant changes the inspection from a nerve-wracking mystery to a manageable process. Patrick Gainer’s record shows a clear pattern of thorough, documentation-heavy reviews with a keen eye for sanitation and labeling. 

This means if you work in food or cosmetics manufacturing, you should treat his profile as required reading and adjust your readiness plans accordingly.

The FDA’s goal is to ensure your facility produces safe, compliant, high-quality products that protect consumers. The better you understand his priorities, the better you can demonstrate that your processes meet that standard.