FDA inspections are crucial for ensuring compliance in food and pharmaceutical manufacturing, and inspector-specific Form 483 data can provide companies with valuable guidance for achieving regulatory success. Eric S Pittman, a Supervisory Consumer Safety Officer based in Chicago, IL, has conducted 101 inspections since 2008, issuing 58 Form 483s and six warning letters.
Pittman’s Form 483 history reveals recurring compliance issues, particularly in areas like recordkeeping and pest control, which carry significant implications for manufacturers. These areas are critical for maintaining product safety, quality, and adherence to regulatory standards.
This blog explores Eric Pittman’s FDA 483 history, examining the compliance issues he most commonly identifies and the lessons manufacturers can learn from them. Manufacturers can use these insights, along with tools like Atlas Compliance, to improve their practices, address vulnerabilities, and ensure smoother inspections moving forward.
What do FDA Inspections Entail?
FDA inspections are essential for ensuring compliance with regulations like Current Good Manufacturing Practices (CGMP) and the Federal Food, Drug, and Cosmetic Act (FDCA). Inspectors assess a variety of critical areas during these inspections, including:
- Recordkeeping and Documentation: Ensuring that all records are complete, accurate, and properly maintained to demonstrate compliance with regulatory standards.
- Facility Sanitation and Pest Control: Verifying that facilities are clean and free from pests, which can compromise product quality and safety.
- Equipment Cleaning and Maintenance: Ensuring that equipment is regularly cleaned and maintained to prevent contamination and ensure proper functioning.
- Process Controls and Work-in-Progress: Checking that manufacturing processes are under control and that work-in-progress is properly managed to maintain product quality.
- Compliance with Veterinary Oversight Requirements: Verifying that animal-based products meet the necessary veterinary oversight and safety standards.
- Corrective and Preventive Actions (CAPA): Evaluating whether manufacturers have effective systems in place to identify and resolve non-compliance issues, as well as prevent recurrence.
These focus areas are vital to maintaining product safety, quality, and regulatory compliance during FDA inspections.
Who Is Eric Pittman?
Eric Pittman is an FDA Supervisory Consumer Safety Officer stationed in Chicago, IL (60661). He has been active since 2008, conducting inspections in the United States, Germany, and Ireland.
His focus on food safety and pharmaceutical compliance makes his findings highly relevant for Atlas Compliance’s audience, including food and pharmaceutical manufacturers, quality assurance teams, and regulatory affairs professionals.
Eric Pittman’s Inspection History
Pittman’s inspection record is substantial, with the following key metrics as of May 2025:
- Total Inspections: 101
- Total 483s Issued: 58
- Total Warning Letters Issued: 6
- Average Inspection Duration: 0.94 days
- Inspection Duration Range: 1–11 days
- Inspections Last Year (2024): 3
- Inspections This Year (2025): 0
Pittman’s short average inspection duration (0.94 days) suggests a focused approach, targeting specific compliance issues. His 58 Form 483s and six warning letters reflect a rigorous stance, with limited activity in 2024 (3 inspections) and none in 2025, possibly indicating a shift in his role.
Key Compliance Issues in Pittman’s 483s
Pittman’s Form 483s highlight recurring compliance issues, with the top five citations focusing on:
- FDCA 402(a)(4): Inadequate recordkeeping, hindering traceability and compliance verification.
- FDCA 501(a)(5): Extra-label drug use without a veterinary client-patient relationship, risking regulatory violations.
- 21 CFR 110.35(c): Lack of effective pest exclusion measures, increasing contamination risks.
- 21 CFR 110.20(b)(4): Poor maintenance of floors, walls, and ceilings, compromising facility sanitation.
- 21 CFR 110.80(b)(5): Inadequate control of work-in-progress, affecting product safety and quality.
These citations, often tied to keywords like “pest,” “cleaning,” and “sanitation,” highlights Pittman’s emphasis on documentation and facility hygiene, critical areas for manufacturers to address.
Recent Trends in Pittman’s 483s
Pittman’s inspection activity has seen a decline, with only three inspections in 2024 and none in 2025. However, his historical Form 483s remain highly relevant, providing critical insights into ongoing compliance concerns. The primary areas of focus in his inspections include:
- Recordkeeping: Citations related to FDCA 402(a)(4), which involves misbranding due to inadequate documentation, continue to be a key compliance issue. This remains a priority for the FDA in both food safety and pharmaceutical manufacturing.
- Pest Control: Issues related to 21 CFR 110.35(c) highlight the importance of maintaining proper sanitation and pest control measures. This is an ongoing concern for manufacturers to ensure product safety and adherence to FDA regulations.
In addition to his U.S. inspections, Pittman’s work in Germany and Ireland highlights the need for global compliance. Manufacturers exporting products to the U.S. must ensure they adhere to FDA standards, regardless of their location. These inspections remind global manufacturers of the importance of meeting FDA expectations to avoid potential issues with U.S. market access.
The short duration of Pittman’s inspections (ranging from 1 to 11 days) suggests that his evaluations are highly targeted. By focusing on high-risk areas like sanitation and documentation, these inspections allow for quick and efficient assessments, enabling the FDA to address compliance issues without extended disruptions to manufacturing operations. This highlights the need for manufacturers to prioritize these critical areas to minimize the risk of violations.
Compliance Implications of Pittman’s 483s
Pittman’s 483 history has significant implications for manufacturers:
- Enhanced Recordkeeping Needs: Frequent FDCA 402(a)(4) citations emphasize the importance of robust documentation to ensure traceability and avoid violations.
- Stricter Sanitation Standards: Citations on pest exclusion and facility maintenance (21 CFR 110.35(c) and 110.20(b)(4)) highlight the need for rigorous sanitation protocols to prevent contamination.
- Veterinary Oversight Compliance: FDCA 501(a)(5) violations indicate that extra-label drug use requires proper veterinary oversight, particularly in pharmaceutical contexts.
- Process Control Improvements: Issues with work-in-progress (21 CFR 110.80(b)(5)) suggest manufacturers must strengthen controls to maintain product quality.
These implications highlight the need for proactive compliance measures to address Pittman’s identified risks.
How to Address Pittman’s Compliance Findings
To effectively address Eric Pittman’s compliance findings and improve overall regulatory readiness, manufacturers can follow these steps:
- Strengthen Documentation Practices: Review Pittman’s Form 483s to identify any deficiencies in recordkeeping. Focus on addressing FDCA 402(a)(4) violations, which pertain to misbranding due to inadequate documentation. Ensuring thorough, accurate, and traceable records will improve overall compliance and accountability.
- Improve Sanitation and Process Controls: Conduct regular audits to verify pest exclusion measures, proper facility maintenance, and controls for work-in-progress. These are critical for maintaining product safety and adhering to 21 CFR 110 requirements, which focus on sanitary conditions and processes in manufacturing.
- Utilize Atlas Compliance’s Platform: Incorporate Atlas Compliance’s AI-powered tools, including natural language processing and predictive analytics. These tools offer real-time access to Pittman’s 483 data, helping manufacturers identify trends, understand common compliance issues, and proactively implement strategies to avoid violations during future inspections.
Conclusion
Eric Pittman’s 101 FDA inspections, 58 Form 483s, and 6 warning letters offer critical insights into compliance challenges, emphasizing recordkeeping, sanitation, and process controls. His 483 history guides food and pharmaceutical manufacturers toward regulatory success.
Atlas Compliance’s platform enables companies to access Pittman’s data, track compliance trends, and build robust regulatory frameworks. Visit Atlas Compliance to discover how their tools can help your organization navigate FDA regulations and achieve compliance excellence.
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