[ HOW-TO GUIDE ]
How to Host an FDA Inspection
Run an FDA inspection from the investigator’s arrival to close-out without losing control of the record.
What a how-to is not
A how-to is SPEQ’s practitioner method, not a procedure. It does not replace your own SOP, it is not a validated approach, and the judgement calls in it belong to your quality unit.
FDA’s Investigations Operations Manual tells investigators exactly how to open, run and close an inspection. Hosting well means having a matching step for each of theirs: who receives them, how requests are handled, how findings are discussed each day, and what is said and committed at close-out. This is that sequence.
- 1
Have the procedure before the visit
Map a hosting procedure to IOM Chapter 5: who receives credentials and the FDA 482, who escorts, how requests are logged, who answers, and how each day ends. Assemble the site’s FDA history — prior inspection reports, 483s, complaints and recalls — because the investigator reviews it before arriving.
- 2
Receive the investigator correctly
The most responsible individual on site receives the credentials and the Notice of Inspection. Record the credential number; do not photocopy the credentials. Confirm the purpose and the areas to be covered, offer an escort, and do not ask the investigator to sign confidentiality letters, waivers or training forms — the IOM says they will not.
- 3
Plan the walk-through and the day
The investigator usually walks the site early to set the depth of the inspection. Escort them along the real process flow, follow gowning and hygiene procedures for controlled areas, and agree working hours and how requests will be passed to the back room.
- 4
Handle every request through the back room
Log each request with the time, retrieve and review the record before it goes out, keep a copy of everything provided, and deliver within the requested timeframe. Give electronic data as complete exports with the query parameters recorded; removing fields, locking worksheets or unreasonable redaction are FDA’s own examples of limiting an inspection. If a record will take longer — translation, off-site storage, a large volume, use on a running operation — say why and agree a time.
- 5
Debrief every day
The IOM expects at least one meeting a day with management to discuss findings that may become written observations. Use it to clarify facts, correct misunderstandings with evidence, and say what is being done. Do not argue; answer.
- 6
Close out deliberately
At close-out the investigator issues the signed 483, explains each observation, and asks what the firm intends to correct and by when. Decide annotations deliberately, commit only to what will be done, and note that an adequate response within 15 business days of the inspection’s end may affect FDA’s decision on further action. A Form FDA 484 is issued for any physical samples taken.
- 7
Hand over to the response team the same day
Give the response team the 483, the request log, the commitments made in the room and the record of daily discussions. After the inspection, the investigator refers contact from the firm to their supervisor and does not comment on whether a response is adequate.
- !Asking for a later start date on a pre-announced drug inspection without a reasonable explanation, which may count as delaying the inspection under section 501(j).
- !Leaving the investigator without people or documents for long periods.
- !Producing incomplete electronic exports, which FDA treats as limiting the inspection.
- !Committing at close-out to dates the organisation has not agreed — the inspection report records management’s response to each observation.
How to Host an FDA Inspection: frequently asked questions
Common questions on host an fda inspection.
Does FDA have to tell us before it inspects?
For drugs, no: FDA usually does not announce for-cause and routine surveillance inspections, though it generally contacts the firm before pre-approval, pre-license and most foreign inspections. For devices, section 704(h) requires inspections other than for-cause ones to be announced a reasonable time ahead; the IOM says domestic pre-announcement should generally be at least five calendar days.
Who should receive the investigator?
The most responsible individual on site — the owner, operator or agent in charge. They receive the Notice of Inspection at the start and the 483 at close-out, and FDA sends a copy of the 483 to top management if that person is not the top official.
Can we stop the investigator taking photographs?
Investigators do not ask permission, because photography is part of the inspection authority. FDA’s 2024 guidance treats impeding photography at a drug or device facility as a possible limitation of the inspection unless there is a documented reason that photographs would harm product quality.
WHERE NEXT
- DO ITOpen the Inspection Readiness Plan template →The structure these steps fill in.
- UNDERSTAND ITFDA Inspections: Readiness and Conduct →The principles behind the procedure.
- ALL GUIDESBrowse all 127 how-to guides →
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