Facing an FDA Audit, Warning Letter, or Recall?

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.

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

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

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.

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.

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.

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

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.

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.

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.