FDA Problems

Struggling with FDA compliance?

At FDA Atty, we are expert FDA lawyers who can offer counsel for dealing with FDA problems. Get expertise on navigating post-market enforcement for FDA imports, FDA inspections, FDA warning letters, FDA recalls, and more.

Most business owners experience a wave of panic when they receive a notice from the FDA

You’re not alone — and you’ve got help. There are so many rules and regulations to follow, and it seems like they are changing daily. When you’re in a highly regulated industry, it’s critical to work with an expert that knows the law like the back of their hand.

At FDA Atty, we work with clients from a wide range of industries ensuring FDA compliance. If your business is regulated by the FDA, our law firm can help you every step of the way. From creating FDA compliance programs, to ensuring you pass FDA inspections, FDA Atty can help.

We can help request an extension so you have more time to come to a favorable resolution for your business — and we can put the structure in place so you don’t experience issues with the FDA down the line.

Feel confident about the future of your business with FDA Atty.


You have a knowledgeable partner by your side

Did you receive an FDA Warning Letter or are your imports held up at the border by customs? Work with an FDA regulatory specialist who understands the many rules and regulations — and can help you meet them. Not only can we resolve the immediate issue at hand, we can pave the way for a smooth future.

FDA Import

Do you need help with a Notice of Action, Form 766 Request to Recondition, or Import Alert? Time is ticking, so contact us to resolve the issue today.

At FDA Atty, we can help you solve your FDA import detention before you suffer other penalties such as FDA warning letters.

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FDA Inspections

Has your facility been inspected, and did you receive a Form 483? You only have 15 days to respond — and we can help you get back to business.

Dealing with an FDA inspection can be stressful. At FDA Atty, we can help you navigate inspection enforcement and prepare a response to Form 483.

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FDA Warning Letters

If you’ve received a Warning Letter, you have 15 days to send in your response. We can prepare your response and get you back in compliance.

Ensure FDA compliance and timely action by hiring our FDA experts. At FDA Atty, we can help you resume operations before getting another penalty.

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FDA Recalls

Don’t let a recall cripple your business. Get ahead of the situation with an FDA expert who can manage every aspect of the recall.

We ensure our client’s FDA compliance and reduce the risk of FDA recalls. At FDA Atty, we can help you business get back on track.

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FDA Consent Decree and DOJ Injunction

If you’ve received this serious FDA enforcement, you need to act fast. Work with us to explore your options before you have to halt operations.

At FDA Atty, we can help your business avoid an FDA Consent Decree. And if you’ve already gotten one, we can help you negotiate the best possible outcome.

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Experience the FDA Atty Difference

Track record of success

With over a decade practicing FDA law, we have worked with a number of clients in your situation, and helped them achieve favorable resolutions.

Area of expertise

You focus on growing your business, while we focus on keeping on top of the ever-changing FDA rules and regulations. We’ll always keep you up to date.

Responsiveness and transparency

We’re available to walk you through the process. You’ll have access to senior counsel to discuss your issue, so you feel empowered to make decisions for your business.

Established FDA connections

Time is of the essence when you’re dealing with a regulatory issue. We are highly connected to the FDA landscape, so we’re able to assist with tight deadlines.

Here’s how to get started

  1. Book your free 20-minute consultation call: Tell us about the issue you’re dealing with and we’ll fill you in on our experience with such matters.
  2. Put a framework in place: We’ll guide you through a regulatory strategy that will help you resolve the immediate issue.
  3. Get peace of mind: After we put out the fires, we’ll focus on ensuring your business remains compliant in the future.

A male lawyer works on his desk, there is a justice scale on it.

FDA compliance is critical to your success. We’ll help you get there.