Few investigators have the extensive experience of Patrick Gainer when it comes to ensuring the safety and quality of FDA-regulated products. As a seasoned Consumer Safety Officer based in Chicago, Gainer has conducted over 180 inspections across multiple countries, providing critical insights into regulatory compliance. 

His inspection reports, particularly Form 483s, offer pharmaceutical and MedTech companies actionable data to stay inspection-ready and mitigate risks. 

This blog explores Patrick Gainer's FDA inspection history, key findings, and how manufacturers can use his data to enhance compliance using tools like Atlas Compliance.

Understanding FDA Inspections

FDA inspections are a key part of regulatory oversight. They ensure manufacturers follow standards like Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP).  These inspections also check compliance with other FDA requirements.

Inspectors focus on several key areas, including:

  • Contamination control and sanitation: Facilities must stay clean. Any sign of contamination can lead to major violations. Inspectors look for proper cleaning procedures and microbial control.
  • Documentation and recordkeeping: If it's not documented, it didn't happen. Inspectors check for complete, accurate, and timely records.
  • Corrective and Preventive Actions (CAPA): Companies must identify problems, fix them, and prevent them from happening again. CAPA systems must be robust and well-documented.
  • Equipment maintenance and calibration: All machines must be regularly maintained and calibrated. This ensures consistent product quality and safety.
  • Employee training and hygiene: Staff must be properly trained. They should also follow strict hygiene protocols to avoid contamination.
  • Labeling and packaging compliance: Product labels must be accurate and clear. Packaging must protect the product and meet regulatory standards.

Understanding these priorities helps pharmaceutical manufacturers prepare for FDA inspections. It also helps them find and fix weak spots in their compliance systems. Patrick Gainer's work shows how inspector data can help companies improve and move toward operational excellence.

Who Is Patrick Gainer?

Patrick Gainer is a Consumer Safety Officer at the FDA, stationed in Chicago, IL (60661). Active since 2009, he has conducted inspections in five countries: The United States, Germany, Portugal, Switzerland, and Italy.  Gainer is a key figure in the FDA's Office of Inspections and Investigations, ensuring that regulated products meet stringent safety and quality standards.

Gainer's inspections cover a range of industries, including pharmaceuticals, food, and cosmetics, making his findings relevant to Atlas Compliance's target audience of pharmaceutical manufacturers, MedTech companies, and quality assurance teams.

Here's how you can connect with Patrick:

Email: Patrick.Gainer@fda.hhs.gov

Phone number: (312-596-4160)

Patrick Gainer's Inspection History

Patrick Gainer's FDA inspection record is extensive, with the following key metrics as of February 2024:

  • Total Inspections: 184
  • Total 483s Issued: 81
  • Total Warning Letters Issued: 0
  • Average Inspection Duration: 3.16 days
  • Inspection Duration Range: 1–37 days
  • Inspections Last Year (2024): 7
  • Inspections This Year (2025): 0

Gainer's inspections span multiple countries, reflecting the global nature of FDA oversight. His ability to identify compliance issues through Form 483s, official notices of observed violations, makes his reports invaluable for companies aiming to align with FDA expectations.

Key Findings from Gainer's Inspections

Gainer's Form 483s highlight recurring compliance issues, with the top five citations focusing on:

  • 21 CFR 110.20(b)(4): Inadequate maintenance of floors, walls, and ceilings, which can lead to contamination risks.
  • 21 CFR 110.20(b)(7): Insufficient screening to prevent pest entry, compromising facility sanitation.
  • 21 CFR 110.35(c): Improper use or storage of insecticides and rodenticides, posing safety hazards.
  • 21 CFR 123.11(b): Inadequate sanitation monitoring which can undermine product safety.
  • 21 CFR 110.35(a): Deficiencies in cleaning and sanitizing operations, critical for GMP compliance.

These citations underscore Gainer's focus on sanitation and facility maintenance, areas that pharmaceutical manufacturers must prioritize to avoid regulatory scrutiny. By analyzing these trends, companies can proactively address similar issues in their operations.

Recent Inspection Trends

In 2024, Patrick Gainer conducted seven inspections, mostly within the United States. His emphasis on sanitation and GMP (Good Manufacturing Practice) compliance reflects key FDA concerns.  

Several citations pointed to issues in cleaning procedures and pest control. This shows that manufacturers must have strong and consistent sanitation practices to meet regulatory standards.  

Gainer also performed inspections in countries like Germany and Italy. These international visits underline the growing need for global compliance, especially for companies operating across borders.

How Patrick Gainer's Findings Benefit Manufacturers

Patrick Gainer's inspection data offers several benefits for pharmaceutical and MedTech companies:

  • Enhanced Inspection Readiness: Gainer's 483s provide a roadmap for identifying and addressing compliance gaps before an FDA inspection. By focusing on recurring issues like sanitation and documentation, companies can strengthen their quality systems.
  • Informed Decision-Making: The detailed insights from Gainer's reports, including CFR citations, enable manufacturers to make data-driven decisions. For instance, addressing pest control deficiencies can prevent costly violations.
  • Trend Analysis: Analyzing Gainer's citation trends helps companies anticipate FDA priorities. For example, his emphasis on cleaning operations suggests that manufacturers should invest in robust sanitation monitoring.
  • Global Compliance: Gainer's international inspections highlight the need for consistent compliance across global facilities, particularly for companies exporting to the U.S. market.

Using Gainer's Data for Compliance

To maximize the value of Patrick Gainer's inspection data, manufacturers can take the following steps:

  • Review Form 483s Regularly: Analyze Gainer's 483s to identify common compliance issues, such as inadequate sanitation or documentation. This helps prioritize internal audits and corrective actions.
  • Incorporate Findings into Audits: Integrate Gainer's citation trends into internal quality audits. For example, focus on verifying pest control measures and cleaning protocols to align with his findings.
  • Use Atlas Compliance's Platform: Atlas Compliance offers AI-powered tools to access real-time inspection data, including Gainer's reports. Its predictive analytics and NLP-driven search capabilities help manufacturers stay ahead of compliance risks.

Conclusion

Patrick Gainer, an FDA Consumer Safety Officer, plays a pivotal role in upholding regulatory standards through his extensive inspection history. His 184 inspections and 81 Form 483s provide pharmaceutical and MedTech companies with critical insights into compliance challenges, particularly in sanitation and GMP adherence. 

With renowned intelligence platforms like Atlas Compliance, manufacturers can access Gainer's data, track inspection trends, and strengthen their quality systems to stay inspection-ready. Visit Atlas Compliance to explore how their platform can help your organization navigate FDA regulations with confidence.