FDA inspections are a cornerstone of regulatory compliance, ensuring that pharmaceutical and food manufacturers meet stringent safety and quality standards. John Emmert, a seasoned Consumer Safety Officer based in Sioux Falls, SD, has conducted over 630 inspections since 2008, issuing 35 Form 483s.
His reports offer critical insights into compliance challenges, particularly in tissue residue and recordkeeping. This blog examines John Emmert’s FDA inspection history, key actions, and how manufacturers can use his compliance data to enhance regulatory strategies using tools like Atlas Compliance.
What FDA Inspections Entail
FDA inspections ensure manufacturers comply with regulations like Good Manufacturing Practices (GMP) and the FDCA. These inspections protect product quality, consumer safety, and public health. Inspectors focus on key areas to verify regulatory adherence:
-
Contamination Control and Sanitation: Ensuring that products are manufactured in an environment free from contaminants is vital. Inspections focus on the effectiveness of sanitation procedures, pest control, and air quality to prevent contamination at all stages of production.
-
Accurate Recordkeeping and Documentation: Proper documentation is essential for tracking production processes, product quality, and compliance. Inspectors verify that records are complete, accurate, and readily accessible, which is critical for traceability and accountability.
-
Corrective and Preventive Actions (CAPA): The FDA requires manufacturers to have systems in place for identifying and addressing issues promptly. CAPA procedures ensure that problems are not only corrected but also prevented through root cause analysis and process improvements.
-
Equipment Cleaning and Maintenance: To prevent cross-contamination and ensure the continued functionality of production equipment. Inspections focus on whether cleaning and maintenance schedules are adhered to and whether equipment is functioning optimally.
-
Product Safety and Withdrawal Periods: Manufacturers must have processes to ensure product safety and identify potential recall issues. FDA inspectors review procedures for identifying defects, withdrawal timelines, and consumer notifications.
-
Facility Condition and Hygiene: The overall condition of the manufacturing facility, including cleanliness, safety protocols, and structural integrity, is assessed. Inspections ensure that facilities are well-maintained and conducive to producing safe, high-quality products.
By aligning processes with these priorities, manufacturers can better prepare for inspections and address potential compliance gaps. John Emmert’s inspection data provides a valuable resource for understanding these expectations.
Who Is John Emmert?
John Emmert, a dedicated Consumer Safety Officer with the FDA, is stationed in Sioux Falls, South Dakota. He has been actively serving in this role since 2008. Throughout his career, he has gained extensive experience conducting inspections both within the United States and the United Kingdom.
His expertise primarily revolves around food safety and pharmaceutical manufacturing, ensuring that production processes meet stringent regulatory standards. Emmert’s findings help ensure the safety and quality of products reaching consumers. By identifying hazards and ensuring compliance with industry standards, Emmert’s efforts protect public health and safety. His expertise is a key resource for professionals navigating regulations and achieving compliance.
John Emmert’s Inspection History
Emmert’s inspection record is extensive, with the following key metrics as of May 2025:
-
Total Inspections: 630
-
Total 483s Issued: 35
-
Total Warning Letters Issued: 0
-
Average Inspection Duration: 0.92 days
-
Inspection Duration Range: 1–38 days
-
Inspections Last Year (2024): 0
-
Inspections This Year (2025): 0
Despite no inspections in 2024 or 2025, Emmert’s historical data remains a critical resource. His short average inspection duration (0.92 days) indicates a focused approach, targeting specific compliance issues such as tissue residue and facility maintenance.
Key Compliance Issues in Emmert’s 483s
Emmert’s Form 483s highlight recurring compliance issues, with the top five citations focusing on:
-
21 CFR 530.20(a)(2)(iv): Inadequate management of tissue residue, critical for ensuring product safety.
-
FDCA 402(a)(4): Deficiencies in recordkeeping, hindering traceability and compliance verification.
-
21 CFR 530.11(d): Failure to address tissue residue issues, increasing regulatory risks.
-
21 CFR 530.11(a): Inadequate establishment of withdrawal periods, essential for preventing harmful residues.
-
21 CFR 225.20(b)(2): Facilities not maintained in a clean and orderly condition, posing contamination risks.
These citations, often tied to keywords like “contamination,” “environmental monitoring,” and “equipment cleaning,” underscore Emmert’s emphasis on product safety and documentation, areas that manufacturers must prioritize to avoid violations.
Trends in Emmert’s Historical Inspections
Although Emmert has not conducted inspections in 2024 or 2025, his data from 2008 to 2023 reveal consistent FDA priorities. Citations related to tissue residue (21 CFR 530.20 and 530.11) and recordkeeping (FDCA 402(a)(4)) highlight ongoing concerns about product safety and traceability.
His inspections in the United Kingdom emphasize the importance of global compliance for manufacturers exporting to the U.S. The lack of recent activity may suggest a shift in his role, but his historical findings continue to inform compliance strategies.
Benefits of Emmert’s Compliance Data
John Emmert’s inspection data offers significant advantages for manufacturers:
-
Enhanced Product Safety: Addressing tissue residue and withdrawal period issues ensures safer products, reducing the risk of regulatory action.
-
Robust Recordkeeping: Emmert’s focus on FDCA 402(a)(4) encourages stronger documentation practices, improving compliance and traceability.
-
Effective Contamination Control: His emphasis on facility cleanliness and environmental monitoring supports robust sanitation protocols.
-
Global Compliance Insights: Inspections in the United Kingdom provide guidance for aligning with FDA expectations in international markets.
How to Act on Emmert’s Inspection Data
To use John Emmert’s compliance data effectively, manufacturers can follow these steps:
-
Analyze 483 Trends: Review Emmert’s 483s to identify recurring issues like tissue residue and recordkeeping deficiencies, prioritizing corrective actions.
-
Strengthen Safety and Documentation: Integrate Emmert’s findings into internal audits, focusing on withdrawal periods, sanitation, and accurate recordkeeping.
-
Use Atlas Compliance’s Tools: Atlas Compliance’s AI-powered platform provides real-time access to Emmert’s inspection data, using natural language processing and predictive analytics to simplify compliance efforts.
Conclusion
John Emmert’s 630 FDA inspections and 35 Form 483s provide a wealth of compliance data for pharmaceutical and food manufacturers. His focus on tissue residue, recordkeeping, and facility maintenance highlights critical areas for improvement.
Atlas Compliance’s platform enables companies to access Emmert’s reports, track compliance trends, and stay ahead of FDA expectations. Visit Atlas Compliance to discover how their tools can help your organization achieve regulatory excellence and maintain inspection readiness.
