When John Emmert FDA arrives for an FDA inspection, manufacturers can expect a thorough, system-level review that leaves no room for guesswork. Emmett has a consistent track record of identifying areas of compliance that signal underlying problems with operational controls, documentation practices, and quality management.
The 483 observations that he has made indicate some trends that pharmaceutical, biotech, and medical device companies that want to get ahead of enforcement efforts can particularly apply. Incomplete investigations and data integrity issues to failures in environmental monitoring, Emmert audits show where most companies fail and what they need to do to stay within the confines of FDA regulation.
Today, in this article, we are going to discuss the most widely mentioned results of the previous audits conducted by John Emmert and how these findings can be applied by manufacturers to enhance their GMP systems and inspection preparedness.
Who is John E. Emmett?
John E. Emmert is an experienced FDA Investigator with over ten years of experience in the inspection of various industries, most of which deal with food and health-related products.
Emmert is a leading Consumer Safety Officer to assess the adherence of manufacturers to Good Manufacturing Practices (GMP) and other FDA rules. The purpose of his work is to help companies remain in compliance with the FDA, reduce risks, and ensure the safety of human health.
Key Stats on John E. Emmert’s Inspections:
- Total Inspections: 630
- Total 483s Issued: 35
- Total Warning Letters Issued: 0
- Longest Inspection: 38 days
- Shortest Inspection: 1 day
- Average Length of Inspection: 0.9 days
Key Areas FDA Inspectors Focus on During Inspections
FDA inspectors such as John E. Emmert conducts inspections on key areas to assess and determine if products are safe and of regulatory quality. Some of the most typical areas during FDA inspections include the following:
- Sanitation and Hygiene Practices: Inspectors assess whether facilities are following reasonable sanitation practices to assist prevent contamination of food, pharmaceutical and medical device manufacturing plants.
- Product Safety and Handling: This is because they need to be able to store, transport and handle their products in a compliant manner. Inspectors seek out the possible risks to the safety of the product.
- Documentation and Record Keeping: It is important to have accurate and complete documentation of the production and quality control processes. The inspectors check whether the companies keep records according to the FDA standards.
- Quality Control Measures: The effectiveness of the quality control system of a firm is often checked by the inspectors, to guarantee that the products offered by the company are safe to reach the market.
Labeling and Packaging Compliance: Mislabeling or inadequate packaging is a frequent concern during inspections, and inspectors ensure that products are accurately labeled as per FDA guidelines.
Key Observations from John E. Emmert’s Inspections
Inspections conducted by Emmert offer valuable information about compliance problems that are recurrent and that manufacturers have to resolve. Form 483s are a regular occurrence, but he has not yet needed to send any warning letters, which means that his inspections do not focus on taking legal action, at least not at the first instance. The following could be considered among the most important findings based on his inspection reports:
Inability to Adhere to GMP (Good Manufacturing Practices)
The most frequent violation observed in the inspections conducted by Emmert is the non-observance of Good Manufacturing Practices (GMP). Unsanitary conditions, a lack of equipment maintenance, or inadequate production process records are all examples of GMP nonconformities. Pollution, product quality issues, and, ultimately, regulatory violations may result from these issues. Best practice: To ensure that manufacturers uphold high standards of GMP, their processes should be audited regularly to ensure that their facilities are clean, that they have proper staff training and that the various procedures are documented.
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Unrecorded or Unfinished Documentation.
Poor documentation of production processes is a common problem in the inspections that Emmert carries out. Documentation is also essential to monitor production, testing and quality control processes to ensure that the company is up to the FDA standards. Poor record-keeping or the inability to maintain the relevant documentation may lead to a failure of an inspection.
Best Practice: Manufacturers must introduce a detailed documentation process, as all the steps of the production process must be documented correctly and should be easily available in case of an inspection.
2. Quality Control Failures
Another similar area of deficiency in Emmert inspection is quality control (QC). These are problems like incomplete product testing, use of low quality material or inability to identify defects in the products before they get into the market. QC failure is potentially dangerous to human health, particularly in the food and medical device sectors.
Best Practice: Have a strong QC system in place with routine testing of products, correct calibration of equipment and corrective measures taken immediately should any of the shortcomings be found.
3. Inadequate Adverse Event Reporting
During certain inspections, Emmert has discovered that the companies do not report adverse events as they should. It is important to report adverse events (defects or consumer complaints), especially in time to avoid exposing products to unsafe situations and exposing consumers to risk.
Best Practice: Be sure that your company has a mechanism to detect and report any adverse events to the appropriate authorities as fast and precisely as possible.
4. Improper Labeling and Packaging
Other issues that Emmert has identified during inspections include labelling and packaging, including incorrect labelling of products, poor storage facilities, or false statements regarding the effectiveness of the products. This could be a lawsuit and a reputation loss to a business.
Best practice: Ensure that all labels and packaging are aligned with the FDA requirements, and the information given regarding the ingredients, instructions on how to use the product and risks is accurate.
Recent Inspections Conducted by John E. Emmert
John E. Emmert also conducted some noteworthy inspections, which include:
- 2021-11-29: Global Sterilization and Fumigation (Sioux Falls, United States)
- 2021-11-23: United Ground Express (Sioux Falls, United States).
- 2021-11-05: Hearthside Food Solutions, LLC (North Sioux City, United States).
- 2021-10-21: Walt Homestyle Foods, Inc. (Yankton, United States).
- 2021-10-15: Bizzy Lizzy Bakery (White, United States)
The trend of these recent inspections is on food production and service companies, which demonstrates the persistence of food safety and appropriate sanitation in the manufacturing process.
Predicting FDA Focus Based on Emmert’s Inspections
Using the trends in Emmert inspections will allow manufacturers to more effectively determine where the FDA is likely to focus its energies going forward. The following may be possible areas of interest in future inspections:
- Food Safety: Due to numerous food manufacturing factory inspections, it is expected that FDA will remain fixated on food safety, sanitation, and proper labeling procedures.
- Medical Device Regulations: As medical devices continue to grow in complexity, FDA inspections are projected to increase in this category, particularly in terms of sterilization and maintenance procedures.
- Supply Chain and Raw Material Sourcing: As the world supply chains increasingly grow complex, FDA inspections could be more concerned with whether the sourcing of raw materials is being done responsibly and safely.
How Manufacturers Can Benefit from Emmert’s Reports
- Active Compliance: Examining the reports of inspections conducted by Emmert allows companies to understand the possible weaknesses in their processes and deal with them before a formal inspection is conducted.
- Benchmarking, Best Practice: The reports issued by Emmert are a benchmark of what the FDA expects the manufacturing company to follow thus enabling the company to practice what was best in the industry.
- Risk mitigation: By defining the typical compliance challenge during the inspections in Emmert, businesses can prevent future risk occurrences and ensure they stay on top of the regulatory demands.
Conclusion
The inspections conducted by John E. Emmert offer invaluable insights into the common compliance problems within regulated companies such as food, pharmaceuticals and medical equipment. Companies can be more proactive, too, and in a better position to meet FDA inspection needs by learning his insights, such as GMP compliance, records, and labeling standards.
Companies seeking to gain a deeper understanding of FDA inspection data and trends can find support from leading intelligence organizations like Atlas Compliance. To make FDA inspections easier and more predictable, they can provide information about inspection trends and assist manufacturers in streamlining compliance activities.