Survive the
Surprise Audit.
The FDA does not announce routine domestic inspections. Our Mock Inspection service identifies compliance gaps before an investigator arrives at your front desk.
Predicted Outcome: Form 483 Issued
What the FDA Looks For
Investigators use the 'Quality System Inspection Technique' (QSIT). They don't check everything; they check systems.
Management Controls
Does executive management review quality data? If you don't have minutes from Management Review meetings, you fail immediately.
CAPA System
Corrective and Preventive Action (CAPA) is the #1 source of 483 observations. Are you closing investigations on time?
Design Controls
For devices: Did you document design inputs, outputs, verification, and validation? 'We tested it' is not enough without the DHF.
The Cost of a Warning Letter
If an inspection ends poorly, you receive a Form 483. If you don't respond adequately within 15 business days, you get a Warning Letter. This is public, scares investors/customers, and can cost $100k+ in remediation consulting to fix.
The Mock Audit Experience
We send a former FDA investigator or certified lead auditor to your facility. We treat it like the real thing.
- 1Arrival & Opening ConferenceWe present our credentials and issue a mock Form 482.
- 2Facility WalkthroughWe inspect production lines, warehouses, and labs for GMP violations.
- 3Record ReviewWe pull random batch records, complaints, and CAPAs to check for completeness.
- 4Closeout & ReportWe issue a mock Form 483 with observations and a graded remediation plan.
Remote 'Front Room' Support
When the real FDA arrives, call us.
For Premium clients, we offer real-time inspection support. When the FDA arrives, you open a secure video channel with our Regulatory Affairs team.
We act as your “Back Room” — reviewing documents before you hand them to the inspector, coaching your subject matter experts (SMEs), and helping you draft strategic responses to daily observations.
Goal: Prevent 483 observations by clarifying misunderstandings in real-time.
The Compliance Roadmap
A transparent, step-by-step workflow from start to certification.
Pre-Audit Review
We review your quality system documentation, SOPs, and recent audit history to scope the mock inspection.
On-Site Mock Inspection
A former FDA investigator conducts a realistic inspection — facility walkthrough, record pulls, and staff interviews.
Mock Form 483
We issue a mock Form 483 documenting observations and ranking them by severity.
Remediation Plan
You receive a prioritized remediation plan with timelines and corrective action guidance.
Transparent, Flat-Rate Pricing
No hourly billing. No hidden retainer fees. Just simple, predictable compliance.
FDA Inspection Readiness
Complete end-to-end management.
Secure Credit Card Payment • Instant Receipt
What's Included
- Mock FDA inspection (on-site or remote)
- QSIT-based audit methodology
- Form 483 simulation with observations
- Graded remediation plan
- Real-time inspection support (Premium)
- Back-room document review coaching
Frequently Asked Questions
Common questions about this regulatory requirement.
Are You Inspection Ready?
Find your weaknesses before the FDA does. Book your gap analysis today.