FDA Import Alerts

We Help Companies Get Off FDA Import Alerts

At MyFDALawyers.com, PC, our FDA import lawyers are committed to helping businesses navigate and resolve problems. Not only do we help companies get removed from import alerts when they are issued, but our team also works proactively to help clients avoid them in the first place. If you have any specific questions or concerns about FDA import alerts, we are more than ready to help. Contact our FDA attorneys today to set up your fully confidential, no-obligation initial consultation.

What is an FDA Import Alert?

An FDA import alert is an enforcement tool that the agency can use to detain certain imported products without actually physically examining each individual shipment. The FDA issues import alerts when it has evidence that a product, manufacturer, or country has violated FDA laws or regulations. All shipments of products subject to an alert are automatically detained and typically refused entry into the U.S. unless the importer provides compelling evidence of compliance. This means that the FDA has shifted its legal burden of proof onto the importer, making the product ‘guilty until proven innocent.’ So, the importer is required to prove that the goods in their shipment no longer violate the law. For some kinds of violation, this is impossible to prove at the importation level, transforming the import alert into a de facto ban on the product. Similarly, the only way off of an import alert is to submit a petition to the FDA that clearly demonstrates that the company on the alert has successfully resolved the violation or violations that got them (or their country) placed on the import alert in the first place.

Import alerts are designed to help the FDA prevent potentially unsafe or noncompliant goods from reaching the American market.

Why FDA Import Alerts Are Issued

A product and its manufacturer are placed on an FDA Import Alert when the FDA determines that the product violates the U.S. Federal Food Drug and Cosmetic Act. Often, FDA places a product on Import Alert FDA (1) found that the product violated the law in some way during import inspection, (2) refused the product admission into the US, and then (3) FDA placed the product and manufacturer on an applicable alert. Almost any violation can get an imported product placed on the alert. The FDA has over 90 different import alerts covering violations related to all FDA-regulated product types (drugs, devices, food, supplements, cosmetics, tobacco, radiation-emitting products, animal drugs and feeds, biological products, and even specific ingredients).

Not all violations lead to being placed on an import alert. For instance, it is uncommon for the FDA to place a company on import alert for a refusal related to minor labeling violations. But refusals for illegal claims or safety-related violations – like, testing positive for illegal pesticides, microbiological contamination (e.g., salmonella), or illegal colors, or for importing a drug or device without the required approval or clearance – frequently lead to being placed on an import alert. Companies and their products will typically be subject to FDA import alert due to severe cGMP violations found during facility inspections, inadequate vetting of foreign suppliers in FSVP inspections, or refusal to allow FDA inspections. Because a company can be put on import alert for a variety of violations, it is critical to have a team with deep and wide working experience with all elements of FDA compliance.

A Proactive Approach Can Help Prevent Import Alerts

An import alert can cause serious financial distress for a company. It is something that you want to avoid whenever possible. Our firm takes a proactive approach to compliance and regulatory issues. By doing so, we can help to reduce the risk of an FDA import alert. Companies should ensure that all products, facilities, and labels meet U.S. regulatory standards before attempting to import. Along with other things, the best practices include maintaining detailed documentation, responding promptly to FDA inquiries, and ensuring compliance through the whole product supply chain. They can also help to demonstrate a company’s good faith and regulatory readiness when the inevitable contact with FDA comes. Our FDA counsel is here to help.

Responding to and Managing an FDA Import Alert

Even if you do everything the right way, your products could still be subject to an FDA import alert. As frustrating as that can be, it is certainly not the end of the road. Our FDA lawyers are here to help you and your company manage and respond to an FDA import alert. Here are the key steps:

1. Review the Alert: First, importers should review the basis of the alert carefully. This means understanding the underlying law or policy, and what that means for your company and product.
2. Gather Evidence of Compliance: Next, importers should work with suppliers and legal counsel to gather documentation demonstrating that the manufacturer has identified the underlying cause of the violation, implemented a corrective action that brings the product or the manufacturer’s manufacturing process into full regulatory compliance, and that the corrective action was successfully resolved the violation. Depending on the situation, it may include lab testing, updated labels, manufacturing records, Corrective and Preventive Action (CAPA) reports, or detailed safety data.
3. Petition for Removal: In almost all cases, companies must submit a petition for removal from the alert, supported by evidence showing the issue has been resolved and will not recur. Until the FDA lifts the alert, products may be detained without physical examination (DWPE). Of course, that disrupts supply chains and can damage a business.

How Our FDA Import Alert Attorneys Can Help

Dealing with an FDA import alert is not easy. It can raise a lot of issues for businesses. Attorneys Rick D. Quinn and Bill Senior are experienced FDA lawyers who have worked for decades to solve problems for clients, including petitioning the FDA to remove companies from import alerts. We have the experience that companies can rely on when it matters the most. More specifically, our FDA attorneys will:

• Develop a Corrective Action Plan: We work with clients to identify the root cause of the FDA import alert and create a detailed corrective action plan that addresses all regulatory deficiencies. Our plans are designed to meet FDA expectations.
• Manage Your Entries into the United States: Our attorneys get detained shipments released routinely and for all kinds of products from around the world. When your shipment or entry is detained or held, they directly engage the FDA on your behalf to both defend your shipments and demonstrate to the FDA that your company has resolved the violations that led to your import alert. If your product can be released, our attorneys can get it done.
• Prepare, Draft, Submit, and Prosecute a Petition: Finally, our firm prepares, drafts (including the supporting evidence required by the FDA), submits, and then advocates on behalf of clients through the formal petition process for removal from FDA Import Alert.