FDA Warning Letters

When the FDA sends an FDA Warning Letter, it’s a signal that something needs to be addressed—fast. The FDA considers Warning Letters to be one of its principal means of achieving voluntary compliance with federal regulations. A Warning Letter is a clear sign that the agency believes your company has committed violations of regulatory significance—those that may lead to enforcement action if not promptly and adequately corrected. Failing to properly address a Warning Letter can lead to serious consequences, including import alerts, product seizures, injunctions, civil money penalties, and other regulatory actions.

At MyFDALawyers.com, PC, we represent companies nationwide facing FDA Warning Letters and related enforcement actions. Our team acts fast, responds strategically, and helps resolve violations before they escalate. With decades of combined experience, our FDA attorneys know how to communicate effectively with the agency and demonstrate your commitment to compliance. If your company has received a Warning Letter from the FDA, we’re here to guide you through every step of the response process.

Responding to an FDA Warning Letter

A Warning Letter is one of the FDA’s most serious pre-enforcement tools. It signals that the agency believes your company has committed significant violations and that immediate correction is required. The FDA issues Warning Letters only for violations it considers to be of regulatory significance. These letters establish “prior notice,” which means the FDA is officially documenting your company’s violations. This documentation becomes critically important if future enforcement actions become necessary.

Your response must be thorough, timely, and tailored to the agency’s concerns. FDA expects a written response within 15 business days of receipt of the Warning Letter. At MyFDALawyers.com, PC, we help clients craft written responses that address each alleged violation individually and include a comprehensive corrective action plan. Your response should detail: (1) each step taken to correct current violations, (2) actions implemented to prevent similar violations, (3) timeframes for completion, and (4) supporting documentation proving corrections have been made. A well-documented, complete response can prevent further action, including import alerts or seizures.

Holds and Detentions Often Follow FDA Warning Letters

FDA holds and detentions don’t usually happen in a vacuum—they often result from unresolved Warning Letters or inadequate responses. If you fail to adequately address a Warning Letter, the FDA may place your products on import alert, detain shipments at the border, or pursue additional enforcement actions. For imported products, an unresolved Warning Letter can lead to your products being detained without physical examination until you demonstrate compliance.

We help clients respond to FDA holds by developing a comprehensive strategy that addresses the underlying violations cited in the Warning Letter. This includes gathering credible evidence, submitting a detailed corrective action plan, and demonstrating sustained compliance. In many cases, we can help negotiate a “Warning Letter close-out letter” from the FDA, which officially recognizes that your violations have been adequately addressed and can help remove import alerts or prevent future detentions.

Why Your FDA Warning Letter Response Matters

FDA enforcement often follows a pattern of escalating actions. The Warning Letter is a critical juncture where you still have the opportunity to achieve voluntary compliance before the FDA initiates more serious enforcement action. Companies that fail to adequately address Warning Letters may find themselves facing import alerts, product seizures, injunctions, civil money penalties, or even criminal prosecution.

Our role is to stop that from happening. We work with clients to:

• Analyze the specific regulatory violations cited in your Warning Letter
• Investigate root causes and develop comprehensive corrective action plans
• Draft strategic, detailed responses to Warning Letters within required timeframes
• Communicate clearly and cooperatively with FDA officials
• Resolve related issues like import holds and detentions

Our approach is proactive, collaborative, and designed to demonstrate not just immediate corrections but sustainable compliance with FDA regulations.

Common Violations Cited in FDA Warning Letters

Warning Letters address violations of regulatory significance. Based on our experience and FDA enforcement patterns, some of the most commonly cited violations include:

• Manufacturing under unsanitary conditions
• Inadequate quality control or recordkeeping
• Misbranding or false/misleading product labels
• Marketing unapproved products
• Failure to follow GMP or other required procedures
• Intentional or flagrant regulatory violations

Each of these violations can result in serious consequences if not addressed promptly and completely. The FDA expects not just correction of the specific violations cited but also implementation of systems to prevent recurrence. We help you investigate, document, and resolve them comprehensively before they lead to enforcement.