Mock FDA Inspections
Mock FDA Inspections Built by Former FDA Investigators
Former FDA investigators help teams test facilities, records, staff answers, and quality systems before FDA inspection activity begins. A focused virtual mock gives teams a remote pressure test with written findings.
Mock FDA inspection readiness
Gap Assessment Services
Mock FDA Inspection Services
Get a private inspection rehearsal that tests the same things FDA will ask for: records, procedures, people, facility areas, and evidence.
Mock Opening Meeting
Practice the first inspection meeting, team introductions, inspection scope, document flow, and room rules before FDA arrives.
- Opening meeting
- Team roles
- Request process
Facility Walkthrough
Walk production, packaging, laboratory, warehouse, cleaning, and quality areas from an FDA investigator viewpoint.
- Area checks
- GMP observations
- Route planning
SOP and Record Review
Review SOPs, batch records, training files, cleaning logs, supplier files, deviations, and CAPA records for inspection gaps.
- SOP checks
- Batch records
- CAPA files
Staff Interview Practice
Test how operators, supervisors, QA, QC, and site leaders answer FDA-style questions about their daily work.
- Mock Q&A
- Role coaching
- Answer review
Gap Assessment Report
Receive a written report that lists findings, record gaps, staff readiness issues, and priority corrections.
- Written findings
- Priority list
- Readiness score
CAPA Planning Support
Turn mock inspection findings into corrective actions, preventive actions, owners, dates, and follow-up evidence.
- Root cause work
- CAPA actions
- Evidence tracking
Why Work With Us
Mock Inspections Built Around FDA Expectations
A mock inspection should show how your team performs under inspection conditions, then turn the findings into a practical correction plan.
Private Pressure Test
Find weak records, uncertain answers, and facility issues before FDA is reviewing them.
Learn MoreFormer FDA Perspective
Consultants test the same areas investigators focus on: procedures, records, training, controls, and evidence.
Learn MoreClear Gap Reporting
Teams receive written findings with priorities, responsible owners, and next-step recommendations.
Learn MoreIndustry-Focused Scope
Mock inspections can cover supplements, food, drugs, devices, biologics, cosmetics, pet food, and animal health products.
Learn MoreCommon Questions
Frequently Asked Questions
A mock FDA inspection is a practice inspection that tests facilities, records, staff answers, and quality systems before FDA conducts a real review.
A gap assessment can include SOP review, batch record checks, facility walkthroughs, staff interviews, CAPA review, supplier file review, and a written findings report.
Yes. Teams can get help with root cause work, CAPA planning, SOP updates, staff training, and follow-up readiness checks.
Yes. Records, interviews, training files, and quality system reviews can be handled remotely. Facility walkthroughs can be done on site or by live video.