Detained Shipment?

Why Following FDA Sampling Guidelines is a Must 

FDA can detain your imported products at any time for any reason. Whether for sampling, testing, or detention without physical examination, when your products are detained, following FDA sampling guidelines and having an FDA sampling plan is a must.  

You can choose whichever FDA import sampling and testing laboratory you wish. But, choosing a laboratory with a long history of handling FDA imports, expertise in FDA sampling guidelines and the ability to seamlessly navigate the FDA import process – and quickly - will help expedite your products’ release.  

In this post, we will show why Certified Laboratories, a Certified Group Company, is the right choice to assist with executing an FDA sampling plan and testing so that your products can be quickly released from FDA detention.


Rapid Response Times 

One of the most dreaded notifications for importers is an FDA Notice of Action. Product detention costs time, money, and risks food product spoilage. If you can’t get your products moving quickly, your customers may look elsewhere. So, expediting the release of your products is a top priority. 

Certified Laboratories’ Import Centers of Excellence are located in major U.S. ports of entry. Our couriers and laboratory scientists work around the clock to ensure your results are accurate and returned quickly so that your products can get moving again.


Expert FDA Sampling Plan & Testing per FDA Sampling Guidelines 

FDA is specific about what it is looking for. Whether routine, random, or for cause sampling and testing, they are seeking answers about imported products that only accredited laboratories can provide. When an FDA Notice of Action is received, our experts spring into action. We verify… 

  • Entry documents 
  • Lines 
  • Lots
  • Product codes to be sampled and tested
  • Product location and packaging
  • Other specific information FDA wants 

Next, we develop a sampling plan based on FDA sampling guidelines and upload the complete package of information into our proprietary Labware system. After generating collection reports and appropriate sample labels, our Samplers are dispatched to the detention warehouse.

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FDA Sampling Guidelines 

FDA needs verification that your detained product’s sampling and testing is conducted in accordance with their defined FDA sampling guidelines.  

By following these guidelines, FDA will have a complete picture of the product in question. Typically, following FDA sampling guidelines translates into samples taken at various locations within the packaged shipment, with cross referencing against photographic confirmation of appropriately labeled cartons and collection points.  

Your samples will be retained and documented in our strict chain of custody, providing confidence that what you shipped is what is sampled and tested. And, thanks to Certified Laboratories established reputation in the industry, FDA can have confidence that their sampling guidelines and plan are met.


Expedited Testing 

Once the samples are received in our laboratories, our scientists expedite the FDA-required tests in our ISO-accredited laboratories.  

Once results are returned, a Certificate of Analysis (CoA) is generated based on the collection report that captures all of the shipment reference information, including line and lot numbers and how many tests were run.  

Testing results, quality control validation and verification, instrument certifications, product labels, and all other necessary items are prepared and signed off by the laboratory director as well as the importer before our seamless submission to FDA. If required by FDA, we also provide method validation documentation and any spikes.

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We Send Submissions Through ITACS 

FDA requires electronic document submissions, and our proprietary Labware software speaks directly to the Import Trade Auxiliary Communication System, known as ITACS. We send required documentation to FDA with a copy to the importer, ensuring both parties have a complete and accurate picture of test results.  

We support thousands of clients each year, helping them understand expectations regarding FDA sampling guidelines as well as expedite testing of their detained products in support of US entry.


Regulatory Support When You Need It 

In addition to FDA sampling and testing, our regulatory consulting team, EAS Consulting Group, facilitates import entry through US Agent services, regulatory assistance with detained products, and more.  

With over 200 former FDA and industry leaders, our regulatory team has experience with the Foreign Supplier Verification Program (FSVP), provides assistance with the expedited entry Voluntary Qualified Individual Program (VQIP), and acts as a Qualified Individual for importers of food into the US.  

Response times vary when it comes to FDA sampling plans and testing programs, and so does expertise. When you receive an FDA Notice of Action, you need to know that your FDA testing laboratory is working diligently and quickly for you.  

Contact Certified Laboratories now to get help with FDA sampling and testing of your detained products