OMIC USA Inc. Announces FDA Import Detention Testing Service
July 2, 2012 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. Illegal residues are often detected through routine sampling, which leads to a refusal of entry for that shipment and automatic detention going forward. Unfortunately for importers, this Detention Without Physical Examination or DWPE (formerly referred to as FDA Automatic Detention) can be a worrisome and confusing situation.
In the face of this ongoing challenge, OMIC USA Inc. (www.omicusa.com) is pleased to announce its capability to test samples and submit analytical packages towards clearance of FDA detention. With a current arsenal of instruments, integral quality system, and highly qualified scientists, we have already successfully submitted a number of packages on behalf of clients who were dealing with the specific problems associated with an FDA Detention Notice.
From start to finish, OMIC USA Inc. handles all of the complicated details. We offer 1) a nationwide network of sampling agents who collect and document samples according to very specific requirements, 2) ISO 17025 accredited analysis for the substance in question, and 3) the experience required to compile the report that will serve as the client’s response to the FDA notice.
Please contact us as soon as possible following receipt of an FDA notice of detention in order to receive assistance in navigating the process and avoid any potential delays.
The U.S. Food & Drug Administration (FDA) has for many years utilized private testing laboratories in determining the quality of foodstuffs imported into the United States. It estimates that importers have used over one hundred private laboratories to generate analytical data in support of claims that imported food products comply with U.S. laws.
OMIC USA Inc.'s analytical laboratory is one of the preeminent laboratories in the United States that works with the FDA and such related programs as the Automatic Detention Program.
The Code of Federal Regulations (CFR) Title 21, Part 59, describes the new regulations for person who use sampling services (services that collect samples for another party) and private laboratories used in connection with imported food.
A Collection Report Form should be used when a sample is taken to the laboratory. The samples need to be properly identified, collected, and maintained.
All reports that OMIC USA submits to the FDA include, at minimum, the following information: