Successfully navigate the process of FDA detention clearance with Element’s comprehensive import detention testing and support services.
The FDA can choose to hold, quarantine, randomly sample, and/or perform confirmatory testing on products intended for market at the time of import. As a result, product can be detained or withheld, requiring testing and submission of analytical packages for clearance. Element offers full-service import hold testing and support, including on-site sampling, testing and regulatory support for United States Food and Drug Administration (US FDA) detentions, including instances where importers encounter Detention Without Physical Examination (DWPE), formerly known as FDA Automatic Detention.
With the ongoing expansion of the Food Safety Modernization Act (FSMA) there is an increasing number of foods and commodities being tested by the FDA at the time of import. Element’s depth and breadth of expertise extends from regulatory compliance to analytical and microbiological testing of a wide range of products, from foodstuffs to supplements, over the counter (OTC), and personal care products, as well as cosmeceuticals, consumer products, and household goods. Our consultative teams of regulatory and scientific experts are familiar with the requirements for sample collection, testing, and analytical package submissions set forth by the FDA to release detained imported products that are proven to be unadulterated and “clean” after testing.
FDA import detention testing services
- On-site sampling
- Testing services
- Regulatory support, including submission of analytical packages
The Element Advantage
When the FDA places an import hold on product, it becomes the responsibility of the importer to make certain those products comply with the FDA's laws and regulations. Element’s teams of regulatory and scientific experts can help you to navigate the process of releasing detained or withheld products with independent on-site sampling, analytical testing, and regulatory support services, including the submission of analytical packages to the FDA.
To learn more about our FDA import detention testing services, or to speak with one of our experts, contact us today.
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