Inspection announced or in progress
FDA is in your facility. Get experienced inspection support now.
Tailwind provides real-time strategic support during active FDA inspections, helping management evaluate investigator requests, prepare SMEs, assess emerging observations, organize evidence, and understand potential regulatory significance.
During an active inspection we can help with:
Support is designed to improve responsiveness, accuracy, organization, evidence control, management awareness, and defensibility while the company remains fully responsible for its FDA interactions.
What to do in the first 24 hours
Whether the inspection is announced or the investigators just arrived, the same fundamentals apply:
- Designate one person to manage the inspection — the host — and one to run the back room handling document requests. Investigators should never wander unescorted.
- Log everything: every request, every document handed over, every question asked. That log becomes the spine of any later 483 response.
- Respond truthfully and promptly to each request. Confirm scope when a request is unclear, preserve the request log, and have appropriate personnel review responsive records before production.
- Correct small, verifiable problems immediately and tell the investigator you did. Documented real-time correction reads far better than a promise.
- Hold a short internal debrief at the end of each inspection day so the team starts the next morning aligned.
What to say — and what not to say — to investigators
Answer the question that was asked
Investigators are trained to let silence work. SMEs should answer truthfully, specifically, and stop. Guessing, speculating, or filling pauses creates statements that cannot be walked back.
Never guess — offer to find out
"I don't know, but I will get you the answer" is a complete, professional response. A wrong answer given confidently is far more damaging than a delayed right one.
Keep opinions out of the room
Characterizations of the company, other sites, other regulators, or past inspections are not helpful to anyone. Stick to facts, records, and practice.
When teams call
- FDA is on site now and the inspection is not going well
- An inspection is announced and the site has not been inspected recently
- A Pre-Approval Inspection is coming for a pending application
- The investigator's questions are moving toward data integrity, sterility assurance, or product disposition
- The inspection closed with a 483 and the 15-business-day response window is running
How support works during an active inspection
The consultant does not speak for your company to the investigator. The value is in the judgment applied between the daily sessions: what the day's questions say about where the inspection is going, which documents to surface before they are asked for, what to correct tonight, and how to prepare tomorrow's interviewees.
Availability and the appropriate remote or onsite approach are confirmed during triage. Onsite support is billed at the standard rate of $5,000 per day per consultant; remote inspection-day support is scoped to the situation.
The clock is already running
Fifteen minutes is usually enough to tell you what the next 48 hours should look like.
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