Prepare
Mock FDA inspections and readiness assessments
A mock inspection is only useful if it feels like the real thing. That means unannounced document requests, floor observation, SME interviews under pressure, and findings written in the language a Form 483 actually uses.
Tailwind Pharma runs mock inspections from the investigator's chair — eight years of FDA field inspections informing what gets asked, what gets pulled, and where a tour turns into an observation.
FDA inspection announced — or investigators already on site?
Get inspection help nowFind the inspection problems before FDA does. A useful mock inspection tests whether procedures match practice, SMEs can explain the system, investigations withstand questioning, and the evidence supports management conclusions.
What the engagement includes
- A multi-day inspection simulation using real inspection technique
- Front-room and back-room process rehearsal, including document turnaround
- SME interview coaching with immediate, specific feedback
- Mock EIR-style inspection report and simulated Form FDA 483 observations where appropriate
- A prioritized readiness plan with realistic closure timelines
- Optional inspection-day support when the real inspection arrives
When teams call
- A Pre-Approval Inspection is expected for a pending application
- You are inside the window for a surveillance inspection
- A new site, product line, or system has not yet been inspected
- Prior observations are believed closed and you want that tested
- Quality leadership or key SMEs have recently changed
Deliverables are consulting work products modeled on FDA inspection practices. They are not official FDA records, findings, or classifications.
How we approach it
Run it, do not review it
A paper gap assessment tells you what your documents say. A mock inspection tells you what your people say when the investigator asks a follow-up question. Both matter; only the second is rehearsable.
Score against classification, not preference
Potential observations are prioritized by regulatory significance so remediation effort goes where the evidence and quality-system risk warrant it. These are consulting assessments, not official FDA classifications.
Leave the site able to repeat it
The deliverable includes the mechanics: request logs, back-room workflow, escalation rules, and interview standards your team can run without an outside consultant next time.
Related services
Common questions on timelines, scope, and cost are answered on the FAQ page, and engagement terms are on pricing.
Tailwind Pharma provides independent advisory services and does not replace the manufacturer's designated Quality Unit or guarantee regulatory outcomes.