This free FDA inspection readiness checklist is for heads of quality, regulatory affairs managers and site leaders at FDA-regulated sites that make drugs, biologics, medical devices or food. One run covers one inspection, from the readiness review to the closed inspection file. It starts with the site’s inspection history and open commitments, runs a mock inspection and closes the gaps it finds, then sets up the inspection team, the front and back rooms and the document request procedure. On the day, it covers credentials and the Form FDA 482, the opening meeting, escorts, the request log, daily meetings and the close-out. When a Form FDA 483 is issued, a response phase appears with the site head’s approval and the 15-business-day response. Choosing the product type and the type of inspection adds the matching steps, such as the device pre-announcement call or the application check for a pre-approval inspection.
Section 704 of the Federal Food, Drug, and Cosmetic Act lets FDA investigators enter and inspect a site that makes, processes, packs or holds food, drugs or devices, at reasonable times and within reasonable limits, once they have shown their credentials and given written notice. That notice is the Form FDA 482. FDA runs surveillance inspections to monitor compliance, pre-approval inspections as part of an application review, for-cause inspections when it has reason to believe there is a problem, and follow-up inspections after earlier violations. At the end, the investigators discuss what they found with management, and any significant objectionable conditions are written on a Form FDA 483.
A 483 is not a final agency decision. FDA weighs it with the Establishment Inspection Report, the evidence collected and the company’s response before it classifies the inspection and decides whether to act. That is why the work after close-out matters as much as the days on site.
This checklist covers one inspection by FDA, from readiness to the closed file. Your own internal audits test the quality system on your schedule; the ISO 9001 internal audit checklist shows that pattern. The CAPA checklist and the root cause analysis checklist run the corrective actions a 483 leads to. Hospitals preparing for an accreditation survey or a CQC inspection in England have their own regulators and methods, covered by the Joint Commission survey readiness checklist and the CQC inspection readiness checklist.
Covers: the inspection history, open commitments, a mock inspection, gap closure, the team, the front and back rooms and the request procedure.
Owned by: the inspection lead and the head of quality.
Output: a site that can find any record quickly and people who can explain their work.
Covers: credentials and the Form FDA 482, the opening meeting, escorts, the walk-through, every request logged and reviewed, daily meetings and the close-out.
Owned by: the inspection lead, the back room lead and the site head.
Output: a full record of what FDA asked for, was given and was told.
Covers: the written response to any Form FDA 483 within 15 business days, corrective actions, the classification and the EIR.
Owned by: the head of quality, with the site head’s approval.
Output: commitments kept and a closed inspection file.
Eight phases take one inspection from the readiness review to the closed file. The product type and the inspection type chosen on the first task add the matching steps. The annotation task and Phase 7 appear only when a Form FDA 483 is issued, and nothing after the site head’s approval of the response can be completed until it is given.
Investigators read a site’s inspection history, complaints, recalls, registration and listing before they arrive. Read the same file first, and answer the two setup questions, because they decide which tasks appear.
A mock inspection only helps if it is run the way FDA runs one: a walk-through first, then records, then the people who do the work, by someone who does not work in the area. The application check and the trigger account appear only for the inspection types that need them.
On the day there is no time to decide who does what. Agree the roles, the rooms and the request procedure now and rehearse them once. The pre-announcement task appears for medical devices, and the advance records task for drugs, biologics and devices.
The inspection starts when the investigators show their credentials and issue the Form FDA 482 to the most responsible individual on site. The date on the 482 drives the due dates in Phases 4 and 5.
Most of an inspection runs through requests: a question in the front room becomes a record found, reviewed and copied in the back room. Log every one, so the response team and the next inspection can see exactly what FDA was given.
At the close-out meeting the investigators read and discuss each observation with management and issue the signed Form FDA 483 before they leave. The close-out date drives the due dates from here, and the annotation task and Phase 7 appear only when a 483 is issued.
Applies only when a Form FDA 483 is issued. At close-out the investigators tell management that an adequate response FDA receives within 15 business days of the end of the inspection may affect its decision on further action. Nothing after the site head’s approval can be completed until it is given.
An inspection is not over until FDA classifies it and every commitment is closed. FDA classifies each inspection as NAI, VAI or OAI, taking into account the response to the Form FDA 483 and the corrective actions proposed or completed.
Every FDA inspection produces the same short set of forms and records. The table shows when each one arrives and what to do with it. It is drawn from FDA’s Investigations Operations Manual 2026, section 704 of the FD&C Act, Field Management Directive 145 and FDA’s page on inspection classifications. Foreign inspections differ: no Form FDA 482 is issued outside the United States, although credentials are still shown.
| Form or record | When you get it | What to do with it |
|---|---|---|
| Form FDA 482, Notice of Inspection | On arrival, after the investigators show their credentials, issued to the most responsible individual on site. One notice covers the whole inspection, not each day. | Record the date, because the inspection starts there. Check that every investigator present has signed it; anyone who joins later issues a new one. |
| Records request in advance (drugs and devices) | Before an inspection, or instead of one, under section 704(a)(4) of the FD&C Act. The request describes the records and the reason for asking. | Send the records within a reasonable time, in electronic or physical form, and keep a copy. FDA confirms receipt. |
| Form FDA 483, Inspectional Observations | At the close-out meeting, signed, before the investigators leave. Each observation is read and discussed with management. | Decide on annotation where FDA offers it. Send a written response with your corrective action plan; FDA tells management that an adequate response received within 15 business days may affect its decision on further action. |
| Form FDA 484, Receipt for Samples | At the end of the inspection, for any physical sample removed from the site. | Check it lists every sample. Records, labeling and photographs get no receipt, so log them yourself. |
| Establishment Inspection Report (EIR) | Written by the investigators. FDA sends the redacted narrative to the site within 45 calendar days of deciding the inspection is closed. | Compare it with your own notes and keep it with the inspection file. |
| Classification: NAI, VAI or OAI | After FDA has weighed the findings, the EIR and your response. | NAI: no objectionable conditions found. VAI: objectionable conditions found, but no action recommended. OAI: regulatory or administrative action recommended. |
What FDA can see. For prescription and nonprescription human drugs and for devices, an inspection extends to everything bearing on whether products are adulterated or misbranded, including records, files, processes, controls and facilities. It does not extend to financial data, sales data other than shipment data, pricing data, personnel data other than the qualifications of technical and professional staff, or research data outside what the law requires to be reported (21 U.S.C. 374(a)(1)). Turning down a request for information the law does not require is not a refusal of inspection.
Delays count. For drugs and devices, delaying, denying, limiting or refusing an inspection, including delaying records without a reasonable explanation, can cause the product to be deemed adulterated under section 501(j). Plan the back room so records arrive quickly, and ask for time only for a reason you can explain, such as compiling a large volume of records or translating them.
The site head’s approval of the 483 response is assigned to them alone, and the checklist halts there. The response cannot be marked sent until every action, date and commitment in it has been approved. See how approvals that halt a checklist work.
The request log, the scribe notes, the findings from each daily meeting and every commitment made to FDA sit on the tasks they belong to, with the 482, 483 and 484 attached. The Reports Grid shows each site’s inspection as tasks are completed, so senior management can follow it without calling the back room.
Readiness tasks count back from your ready-by date, the hosting tasks from the date on the Form FDA 482, and the response from the close-out date, so the 15 business days start on the right day. Choosing drugs, biologics, devices or food adds the matching steps. Change the offsets or add your own SOP steps in the template designer.
CheckFlow does not tell you whether your site complies with FDA regulations, and it is not legal advice or a document control system. It runs the readiness, hosting and response steps in the same order for every inspection, with a record of who did what and when.
This template covers one inspection by FDA. Run the corrective actions a 483 leads to with the CAPA Checklist and the Root Cause Analysis (8D) Checklist, audit your own quality system with the ISO 9001 Internal Audit Checklist and your suppliers with the Supplier Audit Checklist. Food sites can keep their HACCP plan current with the HACCP Food Safety Checklist, and the Annual Compliance Calendar Checklist keeps readiness reviews on a schedule. Running inspections across several sites? CheckFlow’s compliance checklist software keeps owners, evidence and sign-offs in one place.
Describe the process in a sentence and the AI checklist generator drafts the phases and tasks for you.
A Form FDA 483, Inspectional Observations, is issued to a company’s management at the end of an inspection when the investigators have seen conditions that, in their judgment, may violate the FD&C Act and related laws. Each observation is read and discussed at the close-out meeting. It is not a final agency determination and not a complete list of every problem: FDA weighs it with the Establishment Inspection Report, the evidence collected and the company’s response before deciding what to do. Companies are expected to correct both the cited conditions and related ones that were not cited.
FDA’s Investigations Operations Manual tells investigators to advise management at close-out that an adequate response received within 15 business days of the end date of the inspection may affect FDA’s decision on further action. Count the days from the last day of the inspection, leaving out weekends and federal holidays. FDA encourages a written response with a corrective action plan that is then put in place quickly. A response that explains the root cause, the fix, the systemic change and how you will check it worked, with evidence, is more useful than a list of promises.
Start with what FDA already knows: your inspection history, open commitments, complaints, recalls and registration. Then run a mock inspection the way FDA runs one, starting with a walk-through, then sampling records and interviewing the people who do the work, and close the high-risk gaps it finds. Before the ready-by date, name the inspection team, set up a front room and a back room, write the arrival and document request procedures, and brief staff to answer truthfully from their own procedures.
They ask for the owner, operator or agent in charge, show their credentials and issue a signed Form FDA 482, Notice of Inspection, to the most responsible individual on site. They explain the purpose of the visit and usually walk through the site early to plan the inspection. Management may examine the credentials and record their numbers but may not photocopy them. Investigators can sign in and follow your security rules, but are not authorized to sign waivers or confidentiality letters.
Sometimes. Domestic medical device surveillance and premarket inspections are pre-announced at least five calendar days ahead, with the start date, type, expected length and team size, and foreign inspections are usually announced because of travel and access. Drug inspections may be pre-announced at the program division’s discretion, while FDA’s manual says it may generally be inappropriate to pre-announce inspections of food establishments. A pre-announcement is not an appointment, and FDA keeps its authority to inspect for cause without notice.
They are FDA’s three inspection classifications. No action indicated (NAI) means no objectionable conditions or practices were found. Voluntary action indicated (VAI) means objectionable conditions or practices were found, but FDA is not prepared to take or recommend administrative or regulatory action. Official action indicated (OAI) means regulatory or administrative action is recommended. FDA decides the classification from the inspection findings and the information the facility provides afterwards, including its response to the Form FDA 483.
Refusing entry or access to records FDA is entitled to see is a prohibited act under the FD&C Act. For drugs and devices, delaying, denying, limiting or refusing an inspection can also cause the products to be deemed adulterated under section 501(j). The inspection does not extend to financial, pricing and most sales, personnel and research data, and declining to give information the law does not require is not a refusal. Ask for time only for a reason you can explain.
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