How to read an FDA notice of inspection

Before an FDA investigator asks a single question or looks at a single record, they hand someone a one-page form: Notice of Inspection, Form FDA 482. It is easy to treat as paperwork to route to the right person and move past. It is actually the document that tells you what kind of visit this is and what authority it rests on — worth reading closely in the first few minutes, not filed for later.

What the form does and doesn’t establish

Section 704(a) of the FD&C Act gives FDA the authority to enter and inspect, at reasonable times and within reasonable limits, facilities that manufacture, process, pack, or hold FDA-regulated products for interstate commerce — including the equipment, materials, containers, and labeling on site. Form 482 is how an investigator documents that this specific visit is being conducted under that authority. It states the purpose of the visit and is presented alongside the investigator’s FDA credentials, which is worth checking before anything else — you are entitled to see identification confirming who you are dealing with. What the form does not do is tell you anything about the outcome. It carries no judgment about your facility; that only starts to take shape once the walkthrough, record review, and interviews are underway, and it isn’t final until FDA issues an inspection classification afterward.

The first hour matters more than people expect

Domestic inspections are usually unannounced, so the practical work starts the moment the investigator arrives, not before. Have a clear internal process for who greets the investigator, who serves as the point of contact for records requests, and who accompanies the investigator through the facility and takes contemporaneous notes of what is asked and shown — that note becomes your own record of the visit, distinct from whatever the investigator writes down. If the person who should host the inspection isn’t available, you can ask for a brief, reasonable delay; you cannot decline the inspection outright. Refusing entry or otherwise limiting an inspection conducted under proper authority is its own prohibited act under Section 301(f) of the Act (21 U.S.C. § 331(f)), and it creates a problem independent of whatever the inspection would have found. Cooperation, not confrontation, is what keeps a routine inspection routine.

Most inspections end without incident, and the notice itself is rarely the interesting part of the story afterward. But it is the document that starts the clock, and reading it carefully — instead of past it — is what puts you in a position to host the rest of the visit well, whether it ends in nothing notable or in a Form FDA 483 you’ll need to respond to.