FDA Import Alert and Detention Assistance

FDA Import Alerts protect US consumers from products produced at facilities with a known history of violations. After identifying a violation, the FDA can place a product on an Import Alert, allowing them to detain future shipments without needing testing or physical examination. This is known as “detention without physical examination” (DWPE). The FDA publishes the list of Import Alerts on a public portal that allows companies to verify whether they are on the FDA Red List.

Import Alerts can create severe supply chain disruptions if the company doesn’t submit a removal request. Due to insufficient FDA public guidance on removing an import alert, many companies have long remained on the FDA alerts list.

The FDA uses the Red, Yellow, and Green Lists to regulate the import of products based on safety concerns:

● Red List: This list includes companies or products that have previously exported unsafe or non-compliant items. Companies on this list cannot freely import to the U.S.

● Yellow List: Applies to companies under investigation for potential issues. Their products undergo increased scrutiny, but shipments aren’t automatically detained.

● Green List: Companies on this list are exempt from import alerts because they have proven their products are safe. They can import without automatic detention despite broader regional issues.

Petitioning FDA for Removal from an Import Alert

To have its products removed from the Red List of an Import Alert -and placed on the Green List, a company must submit an evidence-based petition to the FDA outlining how it has identified the issue and implemented specific corrective actions to prevent future violations. The company should generally show that the problem has been addressed by providing at least five consecutive shipments without any violations. Supporting evidence can include surveillance records, updated Standard Operating Procedures (SOPs), third-party laboratory or audit reports, etc, which the FDA Division of Import Operations will review.

Assistance with an FDA Import Detention

There may be occasions when your company is not on the Import Alert Red list. Yet, you received written detention communication from the FDA, known as a Notice of FDA Action (NOA), specifying the FDA’s concern regarding your product’s safety, efficacy, or other regulatory compliance violations. Most FDA Notices of FDA Action are generally involved in either of the following:

1) Product sampling and testing

2) Product labeling review

3) Field examination of the product

The FDA can require a sample of your product as part of its regulatory oversight. Each sample is tested in the laboratory to ensure it meets safety standards. FDA may also review the product label to ensure it complies with the FDA labeling requirements, incorporating the review of the list of ingredients, warnings, directions for use, drug, nutrition, or supplement fact panel info, health claims, color additives, product identity, etc., depending on the nature of the product in query. The FDA’s field examination ensures that your product was manufactured correctly, packaged, stored, and transported under the right conditions.

In most cases, the issues raised by the NOA may be addressed by submitting a reconditioning proposal to the FDA, which needs to be approved by the FDA office. Reconditioning a product involves modifying it to comply with FFDCA standards, such as relabeling the goods to address labeling issues or re-sterilizing products to address microbial contamination.

Responses to a Notice of Action can be submitted through the FDA Import Trade Auxiliary Communication System (ITACS) or directly to the local FDA Import office. Responding promptly and professionally to the FDA’s notice is imperative to avoid potential supply chain disruptions. If the importer doesn’t respond to the detention notice or fails to resolve the violation, the FDA may refuse the product’s entry into the U.S. and issue a Notice of Refusal. Once the FDA rejects a shipment, obtaining a release becomes much more challenging.

If you have issues with current detention, FDA Listing Inc. can help you gather the required documentation and submit a complete and evidence-based petition to the FDA for detention release. We can also work with you to create a corrective action plan that brings your products back into compliance and submit a formal petition to request removal from the Import Alert.

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