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Detention Without Physical Examination

U.S. FDA can detain and potentially refuse all company shipments that may violate regulations. If your company has been put on an Import Alert Red List for apparent violations, your shipments will be subject to Detention without Physical Examination (DWPE).

We can 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.

Petitioning FDA for Removal from an Import Alert

If your shipments are continually being detained because of an Import Alert, your company must petition FDA to remove you from a Red List or add you to a Green List. The process requires you to provide evidence of your corrective actions and multiple compliant shipments to be reviewed by FDA’s Division of Import Operations.

Registrar Corp makes the petitioning process easier by helping you gather the required documentation and evidence and draft your written petition to FDA.

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Navigate Import Alerts and Detentions quickly and easily.

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  • Max. file size: 50 MB.

Frequently Asked Questions

Import Alerts result in multiple, continued detentions over time. Import Alerts occur when FDA notices a pattern of non-compliance from a particular company, country, or product type. Shipments can be detained and potentially refused entry at the U.S. border for as long as the product is subject to the Import Alert.

There are two types of FDA Import Alerts. The most common type is a Red List Import Alert. When the FDA notices a pattern of non-compliance from a specific company and product combination and adds them to a Red List, any shipments of the red-listed product from that company will be detained. A Green List is a list of companies that are exempt from a particular Country-Wide Import Alert. A Country-Wide Import Alert is created when FDA notices a pattern of violation with a particular type of product coming from a particular country or region.

The following are examples of products that are on FDA Import Alert and subject to DWPE unless the manufacturer is on a Green List:

  • Dried shark fins and dried fish maws
  • Un-eviscerated or partially eviscerated fish that are salt-cured, dried, smoked, pickled, fermented, or brined
  • Refrigerated (not frozen) raw fish and fishery products that are vacuum packaged, modified-atmosphere packaged, or packaged in a material that is not oxygen-permeable
  • Tamarind products (fresh and/or preserved)
  • Ackees
  • Silver coated almonds
  • Papad and Farfar Wafers From India
  • Soft Cheese and Soft Ripened Cheese from France
  • Papaya from Mexico
  • Vegetable protein products from China
  • Milk Products, Milk Derived Ingredients, and Milk Containing Finished Food Products from China
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