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Depending on the violation, the FDA may require additional evidence to support the petition beyond a third-party lab analysis, such as Manufacturing or processing records GMP/HACCP plans and corrective actions FDA establishment inspections Proof of registration and/or listing Proof of certification by a foreign government or certified body Evidence that labeling violations have been corrected Evidence that the product is in compliance Petitioning to be removed from the Red List of an Import Alert is a detailed and complicated process, so its best to enlist the help of a regulatory expert who can help, such as EAS Consulting Group, a Certified Group company