Question 1

What should I do if I just received an FDA Warning Letter?

Accepted Answer

Act immediately. You typically have just 15 business days to respond. Our attorneys can quickly assess the violations, prepare a strategic response, and help prevent escalation to more serious enforcement actions.

Question 2

How quickly can your team respond to my issue?

Accepted Answer

We prioritize FDA emergencies. In most cases, an attorney will respond within 24 hours to begin assessing your situation and outlining next steps.

Question 3

What industries do you work with for FDA compliance?

Accepted Answer

We serve companies in the food, dietary supplement, cosmetic, and medical device industries — providing industry-specific legal strategies that align with FDA expectations.

Question 4

I’m facing an FDA audit — what should I expect and how can you help?

Accepted Answer

An audit can happen with or without notice. We help you prepare, guide you during the inspection, and respond to any Form 483 observations the FDA may issue afterward — often the difference between resolution and escalation.

Question 5

Can you help if my imported products were detained or put under an Import Alert?

Accepted Answer

Yes. We work to identify the cause, develop a resolution strategy, and assist in removing the alert or securing release of detained shipments to restore your business operations quickly.

Question 6

How do I know if I need to issue a recall — and what’s involved?

Accepted Answer

We assess whether a recall is required and help you navigate FDA protocols. From drafting recall notices to regulatory filings, we ensure the process is legally compliant and reputationally sound.

Question 7

Do you communicate directly with the FDA on my behalf?

Accepted Answer

Yes. We can act as your legal representative in all FDA communications, ensuring responses are strategic, accurate, and positioned to reduce liability.

Question 8

What happens if I ignore or delay responding to the FDA?

Accepted Answer

Delays can lead to escalated enforcement — including seizures, injunctions, import bans, or even criminal prosecution in extreme cases. Early legal action is the best way to limit risk.

Question 9

How experienced is your team in handling FDA matters?

Accepted Answer

Our attorneys have handled hundreds of FDA compliance cases and have resolved 95% of Warning Letters without further penalties. We bring deep knowledge of both the law and the industries FDA regulates.

Question 10

What’s the best way to get started?

Accepted Answer

Fill out our FDA Emergency Intake Form or call us directly. We’ll review your issue and provide a fast, strategic plan to help resolve it with minimal disruption.

Question 11

Do I really need an FDA attorney for compliance? What's the worse that can happen?

Accepted Answer

You don't necessarily NEED an FDA attorney for compliance, but it sure is good to have one on your side. FDA attorneys not only have expertise and knowledge of FDA regulations, but can use the law in your defense if the agency takes action against you. Knowing the law is one thing, but knowing how to strategically apply it is another. Lawyers are trained to do this and do it skillfully.

The worst case scenario depends on the issue, but here are some examples:

• if you are importing, the FDA could hold and detain your products, require you to export back or destroy the products or place your company on a publicly published import alert.
• if your fail to respond to 483 inspection observations in writing, the FDA will issue a warning letter which is publicly posted as well. This can escalate to injunctions, fines and criminal prosecution.

FDA has the authority to issue injunctions, charge criminal fines, and prosecute criminally.

There may also be civil liability from any injured consumers as well as repercussions from other federal and state agencies.

Question 12

What is FDA approval?

Accepted Answer

The phrase "FDA approval" is used very loosely when it comes to product compliance. The FDA only actually "approves" high risk medical devices, pharmaceutical drugs and food and color additives. A majority of products do not receive prior approval from FDA. With that said, importing products does add additional scrutiny as both CBP and FDA review products that enter the United States.

Read more here.

Question 13

Do all products go through the FDA approval process?

Accepted Answer

No, most products are not approved or reviewed by FDA before going on the market. For a majority of products regulated by the FDA, the responsibility for compliance is on the businesses marketing and selling the product(s) to ensure that the items are compliant with FDA regulations prior to marketing and sale. That makes it even more vital that your products are reviewed by an experienced person prior to be placed in the market.

Question 14

My company just had an FDA inspection, what should I do now?

Accepted Answer

At the end of an FDA inspection, you should receive a Form 483. This will list all of the investigator's observations of non-compliance. It is important to respond to these observations as soon as possible as there is a 15 day deadline to respond in writing. Ensuring that the responses are thorough and if necessary, point out instances where you believe the inspector may have been incorrect is of utmost importance.

Many clients attempt to respond on their own, only to find that they later receive a publicly posted warning letter after FDA finds their responses insufficient. Responding in a timely fashion and with thorough responses cannot be stressed enough to ensure your business does not suffer unnecessarily.

Question 15

My company received an FDA Warning letter, now what?

Accepted Answer

The dreaded FDA Warning Letter can stop any company in its tracks. It may come as a surprise and the requirement to respond in 15 working days can be overwhelming. The most important thing to do, is to start working on a plan immediately. Begin compiling a list of the violations, addressing them and documenting a plan for addressing any that cannot be handled right away. Responding within the timeframe with actionable steps taken is key.

Strategy in responses can be the difference between a Warning Letter closeout and continuing FDA action.

Question 16

My imported products were stopped at customs (Notice of Action was issues), what should I do now?

Accepted Answer

The FDA should have issued a Notice of Action if your shipment is being held or detained. This document will outline the non-compliance issues FDA has found. It is important to provide a thorough response as quickly as possible to provide the best chance of having the products released. Knowledge of FDA regulations and requirements is important to ensure that the written response answers each violation appropriately.

Imported products and firms found to be in violation of FDA laws and regulations may also be subject to other enforcement actions including but not limited to seizure by Customs and Border Protection (CBP) or FDA, civil money penalties, bond actions, state embargo/stop sale, food importer debarment, and prosecution.

Question 17

I want to begin selling a new FDA regulated product. How do I get started?

Accepted Answer

The most important aspect of ensuring compliance is ensuring that the product is properly classified. This means that you determine whether the product is a food, dietary supplement, cosmetic, medical device, tobacco product or drug. This is determined by the product's intended use. The intended use can be gathered from the nature of the product as well as any claims made in the marketing of the product. The next step is to ensure that you understand what is required by regulation before you begin printing labels, marketing and manufacturing the product.

Question 18

I want to begin importing products. What do I need to do?

Accepted Answer

The first thing to do is hire a customs broker who has knowledge and experience with CBP regulations and requirements. It is also important to ensure you have or you hire someone who has thorough knowledge of FDA regulations.

Recently enforced regulations like the Foreign Supplier Verification Program for food products can be complex. Having someone with experience in these areas can help.

Question 19

What is the timeframe for getting my products compliant?

Accepted Answer

This varies substantially depending on the product. If you only need a registration, it may be a week. If you require something like a medical device premarket approval it can take a year or more.

Question 20

Is it really worth the money?

Accepted Answer

We get this question often, if not directly, by inference. The real question is, "How much do you value piece of mind?" Not only will the money you spend on the front end give you that piece of mind, but it will likely be substantially less than what you will spend and possibly lose in the case of FDA action against you.

Example for Reference:
Dietary Supplement Label and Ingredient Review Flat Fee: $1000

Estimated Costs:
Customs fees: $250 - $2,000
Attorney/consultant fees for Notice of Action Response: $3,500 - $8,000
Cost to export products back: $1,000 - $3,000
Cost for response to Import Alert: $5,000
Cost for Reconditioning: $5,000 - $10,000
Cost to review labeling and ingredients: $1,000
Cost to reprint all labeling: $3,000

FAQ