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.
FDA Detention Testing Services
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.
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. Our experts offer a range of services, including:
- 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.
FDA Urges Organizations to be Recall Ready
In March 2022, the US Food and Drug Administration (FDA) finalized their guidance to help various regulated industries initiated timely recalls of volatile products. The FDA is designating this as being "recall ready." The final guidance is an update to previously released guidance from April 2019, titled FDA Works to Improve Voluntary Recall Processes. READ MOREWhat You Need to Know About the FDA's 'New Era of Smarter Food Safety' Blueprint
The FDA’s "New Era of Smarter Food Safety Blueprint" builds upon the foundation created by the Food Safety Modernization Act (FSMA), which established both risk- and science-based protections in the food supply chain by focusing on and implementing a preventative approach to foodborne illnesses, rather than a reactive one. READ MOREMore Services from Element
Antimicrobial Testing
With more than 30 years of experience, we are the premier contract antimicrobial testing laboratory and expert partner to the developers, manufacturers and users of antimicrobial pesticide and biocide products.
Food Microbiology
Element provides food microbiology services for common foodborne pathogens, food spoilage organisms, and mycotoxins to HACCP, SQF, and R&D programs.
Food Quality and Safety
Element's food safety testing will help ensure that your food product is safe, quality, and fit for the public.
Material Sciences Testing
Element offers comprehensive materials testing capabilities to provide you with the guarantees you need for safety, quality, and performance.