Puzzle

Struggling to stay compliant with ever-changing FDA laws?

Get expertise on navigating post-market enforcement for imports, inspections, warning letters, 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.

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.

Notice

You have a knowledgeable partner by your side

Did you receive a Warning Letter from the FDA 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.

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.

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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.

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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.

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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.

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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.

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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.

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