Onsite GMP Regulatory Inspection Readiness

Mock FDA Audits, Run Like the Real Thing

The fastest way to find out how an inspection will go is to hold one yourself. We inspect your facility the way an FDA investigator would: walking the floor, pulling records, following your processes from receiving of ingredients to product out the door, and interviewing the people who do the work. You get a findings report in the same style as a real inspection, with prioritized gaps and clear corrective action steps, while there is still time to fix them quietly.

• Full mock inspection, onsite at your facility
• Findings report with risk classification
• Documentation and batch record review
• Corrective action plan with realistic timelines

Preparing Your People, Not Just Your Paperwork

Inspections are conversations, and nervous or unprepared answers create findings that the paperwork never would have. We train your team on how investigator questions actually sound, who should answer what, and how to present records confidently. For teams that want structured sessions, we also deliver inspection readiness training and webinars through our GMP training programs, onsite or remote.

• Staff training on investigator questions
• Front room and back room roles and process
• Document retrieval practice under time pressure
• Inspection readiness webinars and workshops

During and After the Inspection

When an inspection is scheduled or already underway, we support your team through it, and when it ends we help you respond. That includes drafting responses to 483 observations, communicating corrective commitments FDA will find credible, and standing up the corrections themselves. Where findings are serious, our GMP remediation programs take the response from letter to verified fix.

We are headquartered in Los Angeles and conduct onsite inspection readiness work across California and nationwide, with remote preparation available wherever you are. See the full range of our quality assurance consulting services.

Inspection Readiness Questions

What happens during a mock FDA audit?

We inspect your facility the way an FDA investigator would: walking the floor, pulling records, following your processes, and interviewing staff. You get a findings report in the same style as a real inspection, so you can fix the gaps before FDA finds them.

How far in advance should we prepare?

Earlier is better, because meaningful corrections take time. A mock audit two to three months ahead leaves room to close gaps properly. If an inspection is already scheduled, we can still prepare your documentation and your team on short notice.

Do you offer remote inspection preparation?

Yes. Documentation review and staff preparation work well remotely via live video, and we deliver inspection readiness training and webinars for teams. Mock audits are most effective onsite, where we can walk your floor the way an investigator will.

What if we already received a 483 or warning letter?

Then the work shifts from preparation to response and correction. We help you respond to the observations and, where findings are serious, build a structured remediation program that closes them out and holds up on re-inspection.