FDA Inspections & Warning Letters
The Food and Drug Administration (FDA)

The Food and Drug Administration (FDA) has the authority to investigate companies through their FDA inspections and examine their products and records under the Federal Food, Drug, and Cosmetic Act (FDCA).

The FDCA also allows FDA investigators to enter any facility that makes, processes, labels, or simply holds foods, supplements, drugs, cosmetics, medical devices, and tobacco products in this country.


The FDA even has the right to come into your facility, examine and sample (for testing) your products, and review your records – if your facility is located in another country but you intend to sell in the U.S.

However, the FDA does not have unlimited rights to look at your records and the FDA must follow its procedures. An FDA attorney can help you through each step so that you don’t end up in legal trouble or wasting time and money

FDA Inspections: The Process

The FDA begins its inspection by showing up and presenting their credentials. Sometimes the investigator will contact you in advance to schedule the inspection, but advanced warning is not required. Their only limitation is to inspect at reasonable times and within reasonable limits. This just means that they should visit during regulator business or operation hours.

If the FDA visits your facility, you are required to allow them to inspect. The FDA does not need a warrant for this inspection. Refusing a legally authorized inspection is a prohibited act under the FDCA, which can lead to civil and criminal prosecution.

When the inspection begins, you’ll receive a written notice, referred to as Form 482.   During the inspection, the FDA has the right to inspect your storage, production, and processing of FDA-regulated products.

The investigator also has authority to review your records pertaining to your company’s compliance with FDA regulations, such as conformity to labeling rules, Good Manufacturing Practices (GMPs), Quality System Regulations (for devices), or newer provisions of the Food Safety Modernization Act (FSMA), such as your Foreign Supply Verification Program (FSVP) or Preventative Controls.

Finally, the FDA has the authority to sample your products to test them for safety.
The FDA must issue you a receipt (Form 484 – “Receipt for Samples”) for any sampled items removed from your facility.

The FDA does not have the authority to inspect or copy personnel data that is not related to required qualification, financial and sales data, or pricing information.

At the end of the inspection, the FDA will give you a Form 483 – Inspectional Observations (“a 483”). A 483 is a written record of anything that the FDA found lacking in your compliance.

Once the inspection is complete, the investigator will create an Establishment Inspection Report (EIR) – which you will get at a later date. Before leaving the facility, the investigator will try to get you to sign an affidavit that contains information about the inspection.

You do not have to sign it. In fact, you should never sign it, comment on the truth or falsity of it – even if they read it to you. Not signing or acknowledging the document is not a failure to comply and there are no consequences for refusing.

If you feel you need to say something, tell them that you will not sign, and any such documents need to be reviewed by your lawyer.

The difficulty here is that you will feel compelled to try to make nice with the FDA.

Be kind, but firm about not signing. Investigators are trained to get you to give them as much information as possible. Ultimately, the FDA investigators want a record that they can pin on you and your company. The government can use the signed affidavit against you and your businessas an admission of guilt if your case ends up in a judicial enforcement action.


Once the inspection is over, you need to formulate a response to the 483 observations. The FDA will request that you respond to the observations within 15 business days. We can help you get an extension if that is necessary.

Promptly and expertly answering the FDA’s observations correctly is critical to closing out the inspection process without further FDA enforcement action – which could pull you into court, cost you significant money, and harm your reputation.

FDA Inspections Warning Letters

The results of the inspection are sent to higher-level FDA compliance personnel. If they determine that there are serious violations that the 483 is not adequate to address, then they will issue a Warning Letter.

A Warning Letter is a pre-enforcement letter intended to get your company to “voluntarily” come into compliance. If, after a Warning Letter, you fail to demonstrate to the FDA that you are now compliant, then the Agency could refer your case to the U.S. Department of Justice attorneys for more serious and judicial enforcement action.

Warning Letters are public (See here), which can harm your brand.
A Warning Letter will list all the violations that the government alleges your company has committed.

These typically include charges about the safety and sanitation of your products (“adulterated” see below) and also charges related to the truthfulness of your product labels and labeling (“misbranded” see below).

At the bottom of your Warning Letter, the FDA will explain what they need in response to the Warning Letter. They will give you 15 business days to resolve all the alleged violations. It is important to thoroughly respond to each allegation in the Warning Letter.

This means understanding and correcting all violations, creating a process for avoiding the same problems in the future, and presenting it all to the FDA in an easy to read and well-documented presentation that will convince them to close-out the Warning Letter and take no further enforcement action.

Terms to Familiarize Yourself With
Learning these terms will help you understand the FDA inspection process.

FDA Form 482 – The written and signed notice the FDA gives you at the start of the inspection.

FDA Form 483 (“Inspectional Observations”) – The form the investigator gives you that lists all the problems they allege about your operation. You must respond to the 483 with remedial actions.

FDA Form 484 (“Receipt for Samples”) – A form the FDA issues to you when they take samples off the premises.

Affidavit – The document that the FDA will try to get you to sign and admit to violations. Do not sign this without attorney review.

EIR (Establishment Inspection Report) – The investigator’s report.

Warning Letter – A public official’s warning that documents the FDA’s allegations that your operations and/or products violate the law.

Adulterated – The product violates FDA law by being unsafe, unsanitary, contaminated, filthy, or otherwise improperly made.

Misbranded – The label or labeling violates FDA law because it has false or misleading statements, or otherwise lacks required label or labeling statements.

How an FDA Attorney Can Help

We can help you with all of the procedures related to pre-inspection, inspection, and responses to FDA 483 Observations or Warning Letters. We also help businesses evaluate current processes and labeling before the FDA ever comes to your facility.

We will help you with the following:

Pre-Inspection Compliance Consultation

We can review your products, labels, and your process documentation to help you avoid inspection violations.

Inspection Representation

We can attend your inspection if you have advanced notice, or we can be on-call for phone representation to make sure your interests are protected and the FDA does not overstep their authority. More importantly, we can help you evaluate the risks related to what the FDA is investigating.

Post-Inspection Response

We can help you evaluate the FDA’s 483 Observations or Warning Letter, help you develop a corrective action plan, help your staff implement any necessary changes to your processes or labels, draft a clear and concise response to the Agency, and respond to any FDA feedback.

Solve Your FDA Problems
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