Explaining FDA Detention and Import Alerts
The FDA performs regular inspections and checks to ensure that imported food adheres to US standards concerning pesticides, pathogens, and additives. When a product is found to contain pesticides exceeding the tolerance or MRL (maximum residue limit), the importer is placed on Import Alert. When a shipper is on the Import Alert list, the FDA requires additional evidence that each subsequent shipment is suitable for entrance into the US. Essentially, each shipment is on hold until the importer can prove it meets US standards. The FDA calls this “detention without physical examination” (DWPE). In an effort to free up agency resources, this evidence can be submitted in the form of a third-party private laboratory report conducted by a laboratory unaffiliated with the FDA.
PrimusLabs offers comprehensive services to assist in this process, including sampling, analysis, and submission of a final analytical packet directly to the FDA. The FDA requires 10 subsamples be taken from each shipment from the shipper’s premises, which is done by a trained and qualified PrimusLabs sampler, who must also fully document the sampling with pictures. The samples are then rushed to the laboratory for processing. The ten subsamples are homogenized in a large grinder and concentrated/extracted for analysis, typically using the Quechers AOAC 2007.01 extraction method. Our chemists will then analyze the samples using GC-MS/MS or LC-MS/MS technology while adhering to the FDA’s stringent protocols. After analysis, an analytical packet (often approaching and exceeding 100 pages) is submitted directly to the FDA.
The packet will then be reviewed by the FDA and the shipment released for distribution if found to be in compliance. After five consecutive passing submissions, the shipper will be removed from the Import Alert list and free to resume normal operations. With over 30 years of FDA detention experience, PrimusLabs is knowledgeable and skilled in quickly and efficiently assisting shippers as they work through the Import Alert process and free up their product for distribution.