How to Receive and Respond to FDA Form 482: Notice of Inspection

FDA Form 482 is the Notice of Inspection that an FDA investigator hands to the owner, operator, or senior manager of a facility at the start of an inspection. You do not fill it out. It arrives already completed and signed by the investigator, and accepting it means the government is legally authorized to begin examining your operations right then. How you respond in the first few minutes shapes the rest of the inspection and any enforcement that follows.

The Legal Authority the Form Represents

The notice requirement comes from Section 704(a) of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. § 374. That statute lets FDA officers enter and inspect any factory, warehouse, or establishment where food, drugs, devices, tobacco products, or cosmetics are manufactured, processed, packed, or held for interstate commerce. Before entering, the investigator must present two things: official credentials and a written notice to the owner, operator, or agent in charge.¹ Form 482 is that written notice.

The same statute requires inspections to happen at reasonable times, within reasonable limits, and in a reasonable manner, and to be started and completed with reasonable promptness.¹ Portions of that statutory text are printed on the front and back of the form itself, so you can read the legal basis while the investigator stands in front of you.²

What the Form Says and Who Gets It

The form is short. The investigator completes it before or on arrival. It shows the date and time of arrival, the legal name and physical address of the establishment, the investigator’s printed name and signature, and the name of the person at the facility who receives it, typically the top management official on site.² You are not required to sign it. The investigator presents you with a completed original that they have already signed.

If additional FDA personnel join the inspection, each one must show credentials to management, and a new Form 482 must be issued for each additional investigator.² Non-FDA officials who may come along, such as state inspectors or subject-matter consultants, do not sign the Form 482 and must separately obtain your permission to enter.

What to Do the Moment You Receive Form 482

Before anything else, the investigator should introduce themselves by name, title, and organization and show their official FDA credentials. Those credentials consist of a photo identification card and a document specifying the holder’s general authority.³ If they don’t offer credentials, ask.

Once the form is in your hand:

Read it carefully. Confirm the date, time, address, and investigator’s identity match what you’re seeing. This record becomes part of the permanent inspection file.
Note who received it. That person acts as the facility’s legal representative for the inspection. If they are not the most senior official available, get one involved right away.
Offer an escort. The FDA’s own manual instructs investigators to readily accept a management offer to have a representative accompany them. Always make the offer. An escort lets you see what the investigator examines, take parallel notes, and confirm they only access records you’re required to produce.²
Contact legal counsel. Nothing in the statute or FDA procedure prevents you from calling your attorney. The inspection will proceed, but counsel on the phone, or on site if practical, helps you make real-time decisions on scope and record requests.

What the Investigator Can and Cannot Examine

Scope depends on what your facility produces. The statute draws a real line between food operations and drug, device, or tobacco operations.

Food Facilities

For food manufacturers, processors, and distributors, the inspection covers the physical premises, equipment, finished and unfinished materials, containers, and labeling. Record access is more limited. The FDA can review records described in 21 U.S.C. § 350c only when the specific standards for records access under that section are met.¹ In practice, food inspections focus on physical conditions, sanitation, and process controls rather than exhaustive document reviews.

Drug, Device, and Tobacco Facilities

For facilities that make prescription drugs, over-the-counter human drugs, medical devices, or tobacco products, the scope is far broader. The statute authorizes access to “all things therein,” including records, files, papers, processes, controls, and facilities, that bear on whether products are adulterated or misbranded.¹ Investigators at these sites routinely review batch records, laboratory test results, deviation reports, standard operating procedures, and training documentation to check compliance with current Good Manufacturing Practices.

Even at drug and device facilities, some records are off-limits. The investigator cannot demand access to financial data, pricing data, sales data other than shipment records, or personnel files beyond the qualifications of technical and professional staff. Some research data is also exempt unless it falls under specific reporting requirements for new drugs, devices, or tobacco products.¹ Provide only the records the investigator is entitled to see, and flag requests that stray into protected territory.

Photography

This is a genuinely ambiguous area. Section 704 authorizes inspection in a “reasonable manner” but does not explicitly mention photography or video. No court has squarely ruled that the FDA has an absolute right to photograph during an inspection. The two cases most often cited on the point, Dow Chemical Co. v. United States and United States v. Acri Wholesale Grocery Co., do not establish a blanket right to mandatory photography.

In practice, FDA investigators are trained to begin taking photographs without asking permission. If you object, the investigator may cite case law and characterize your refusal as impeding the inspection. The FDA has issued warning letters to companies that blocked photography, treating it as obstruction. Whether a court would uphold that position if challenged remains an open question, but objecting carries real enforcement risk.

What Happens If You Refuse the Inspection

If you refuse entry after the investigator presents Form 482, the procedure is straightforward: the investigator leaves the completed Form 482 at your facility, departs, and contacts a supervisor for instructions.² What follows is not pleasant.

Refusing an inspection is a prohibited act under 21 U.S.C. § 331(f).⁴ A first violation can lead to up to one year of imprisonment, a fine of up to $1,000, or both. A second conviction, or a first violation committed with intent to defraud or mislead, carries up to three years imprisonment and a fine of up to $10,000.⁵

The practical consequences can be worse than the criminal ones. For drug manufacturers, refusing or limiting an inspection can cause the FDA to deem products adulterated under 21 U.S.C. § 351(j), which effectively makes them illegal to sell.² For foreign facilities, refusal can trigger import alerts and cancellation of the facility’s food facility registration. The FDA can also seek an administrative inspection warrant from a federal court.

What Comes After: Form 483 and Classification

Form 482 starts the inspection. Form 483 is what you may receive at the end. If the investigator observes conditions that appear to violate the FD&C Act, they document those observations on FDA Form 483, Inspectional Observations, and present it to facility management at the close of the inspection.⁶ Not every inspection produces a 483. If no objectionable conditions are found, you won’t receive one.

A Form 483 is not a final agency determination or a finding of violation. It reflects what the investigator personally observed. The FDA advises companies to respond within 15 business days, explaining corrective actions taken or planned. The agency doesn’t expect every problem to be fully resolved by then, but it wants to see that you understand the observations, have a plan, and have started acting on it. Responses that arrive after the 15-day window generally won’t be factored into any warning letter that follows.

After the inspection, the FDA classifies the outcome into one of three categories:⁷

No Action Indicated (NAI). The facility is in acceptable compliance. Usually no Form 483 was issued.
Voluntary Action Indicated (VAI). Objectionable conditions were found, but the agency expects voluntary correction. A Form 483 was usually issued.
Official Action Indicated (OAI). The facility is in an unacceptable state of compliance, and the FDA may pursue warning letters, injunctions, or consent decrees.

A Note on Remote Regulatory Assessments

The FDA also conducts Remote Regulatory Assessments, which review records and information without a physical visit. An RRA is not an inspection, and the agency will not issue a Form 482 or a Form 483 as part of one. The FDA may provide a written list of observations if it identifies potential violations during the remote review. You can decline a voluntary RRA, but doing so may delay the agency’s response to pending applications or filings.

1
Office of the Law Revision Counsel. 21 U.S.C. 374 – Inspection
2
Food and Drug Administration. Investigations Operations Manual – Chapter 5 Establishment Inspections
3
Government Publishing Office. 21 CFR 5.35 – Credentials
4
Office of the Law Revision Counsel. 21 U.S.C. 331 – Prohibited Acts
5
Office of the Law Revision Counsel. 21 U.S.C. 333 – Penalties
6
Food and Drug Administration. FDA Form 483 Frequently Asked Questions
7
Food and Drug Administration. Inspection Classification Database