Preapproval Inspection Preparation

Mock Inspections allow your drug product or device manufacturing facility to be prepared for an anticipated upcoming regulatory inspection by undergoing the rigors and scrutiny of a "live fire" experience.

Mock Inspections will test and evaluate the readiness of your personnel and systems to deal with the various aspects of regulatory inspections. Our Mock Inspections are conducted by seasoned and highly skilled ex-FDA inspectors who will bring a level of authenticity that can only be matched by real Preapproval Inspections. One of the greatest advantages of a Mock Inspection is at anytime our inspector sees a breach of inspection etiquette, a time out will be taken to coach personnel on the most effective way of handling the situation for a real PAI.

Jeff Yuen and Associates provides ex-FDA inspectors from the wide array of regulated products that are most likely to be much more seasoned and experienced than the real regulatory inspectors themselves. We have a perfect record of successful regulatory Pre-Approval Inspection using our Mock Inspection experience.

PAI Preparation Process

Mock Inspections should be completed at least 2-3 months before an anticipated regulatory inspection to allow ample time to address and correct any identified gaps in the Quality Systems or personnel behavior. Mock Inspections are often conducted between 2 and 5 days. A 5-day Mock Inspection using 2-3 Mock Inspectors will provide the closest thing to a legitimate regulatory inspection experience.

Jeff Yuen and Associates Mock Inspections are conducted the same as most Regulatory Inspections. They start with the initial presentation of the Mock Inspector Credentials and Inspection Notice Forms followed by an opening presentation by the Firm and a tour of the facility and laboratories. After the facility / lab tour, mock Inspector(s) begin evaluating the robustness of various Quality Systems by reviewing approved procedures, scrutinizing completed documentation, interviewing personnel, and witnessing manufacturing operations. The precise Quality Systems that will be evaluated will be determined by the number of Mock Inspectors, number of Mock Inspection days, type of manufacturer, and scope of work. Daily wrap up meetings will be conducted to present identified regulatory compliance gaps and inspection readiness short-comings. A final Mock Inspection close out meeting will be held the last day to provide an overall assessment of inspection readiness and summarize the Mock Inspection findings. A final Mock Inspection Summary Report and Findings will be provided within 5-10 business days.