FDA Red List Removal Services
Our expert compliance team takes the guesswork out of the exemption process, working closely with your business to get your products moving across the border again.
Our 5-Step Path to Red List Removal
We handle the complexities of the FDA’s Division of Import Operations (DIO) so you can focus on your business. Here is how we get you cleared:
1. Identify the Root Cause We start by reviewing your specific Import Alert number on the FDA database. By pinpointing exactly why your product or facility was listed—whether for pathogens, mislabeling, adulteration, or misbranding—we lay the groundwork for a successful resolution.
2. Develop a Corrective Action Plan Our experts conduct a thorough root cause analysis to determine what led to the violation. We then help you implement customized corrective actions, from upgrading food safety protocols and quality control measures to updating vital documentation.
3. Gather Evidence of Compliance The FDA requires proof that your corrective actions work (typically a minimum of five consecutive compliant shipments). We guide you through this logistics process and coordinate any required laboratory testing through LAAF-accredited facilities, such as Mérieux NutriSciences.
4. Submit a Formal Petition We handle the paperwork. Our team prepares and submits a robust "Request for Removal" (Petition for Exemption) to the FDA. We ensure your petition includes a detailed explanation of actions taken, revised HACCP plans, supplier verification, lab results, and proof of compliant shipments.
5. Manage the FDA Review Process Once submitted, we monitor your petition's status. The FDA will assess the request and may conduct facility inspections or additional sampling. We support you through this final hurdle until the FDA issues the official letter confirming your removal from the Red List.
Contact us today to learn more.
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