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FDA Detention Testing Lab

 

Partnering with you to get your product through customs

The FDA regulates the importation of food products into the United States. Its role is to govern the quality and its subsequent safety for human and animal consumption. Detainment of suspect product has made private laboratory testing an integral part of the FDAs work. Eurofins is a member of ACIL, and has a long working relationship with the FDA. Our portside locations, professional staff, and state of the art facilities, make us a valuable partner. 

Our ISO 17025 accredited laboratories have set in place several FDA testing suites; some examples include melamine, drug residues and pesticides. The fast and efficient response to such crises, while working with the FDA, has provided us with cutting edge techniques and methods accepted around the world by many international facilities. By working closely with the FDA throughout the United States, the Eurofins network of laboratories has established an efficient and consistent reporting format for FDA agency acceptance.

 

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Sample Collection

The appropriate and representative sampling of a product is crucial in assuring that the analytical work is accurate. It is necessary that the sampling collection is documented with the following data:

  • Size and description of a lot
  • Size and method of collection
  • Identity of the sampler
  • Date of collection

Analytical Package

All reports submitted to the Food and Drug Administration by the Eurofins Central Analytical network of laboratories contain documentation associated with the sampler. This information must be on file with FDA, be properly signed, and include dated worksheets that cover:

  • Sample preparations and any modifications
  • Methods used and any modifications, instrumentation, calibrations, and conditions.
  • Calculations and results
  • Any other necessary information
  • Source, preparation, and purity of standards
  • All chromatograms or spectra
  • Requirements

To aid the Food and Drug Administration in evaluating the quality of our work and to help them in assuring the accuracy, validity, and reliability of our results, we provide or make available the following:

  • Curricula vitae of personnel
  • A list of each type of analysis and imported commodity handled by the laboratory
  • A list of equipment used for conducting the analysis
  • Updated and accurate quality control records
  • Appropriate FDA Laboratory Information Bulletins (LIB's)
  • Updated compendia if the latest official methodologies (AOAC, BAM, etc.)

Types of Analysis Performed

Chromatographic Analysis employing GC-MS, HPLC, and LC-MSMS, which includes:

  • Pesticides
  • Indole
  • Veterinary Drug Pesticides
  • Melamine and Cyanuric Acid

Chemistry Analysis which include

  • Histamines

In order to maintain laboratory compliance, it is imperative that the laboratory is up to date on all Food and Drug Administration Methodologies and Analytical Practices. Subsequently, the Eurofins Central Analytical network of laboratories maintain an extensive library that among other titles, includes, Official Methods of the USP, European Pharmacopoeia Protocol, AOAC, AACC, and AOCS, BP as well as FDA Bacteriological and Pesticide Analytical Manuals (BAM and PAM). We also house:

  • FDA Laboratory Information Bulletins (LIB's)
  • Current Journals including JAOAC, Journal of Agriculture and Food, Journal of Food Science
  • FDA Compliance Policy Guide
  • FDA Inspection Operations Manual
  • FDA Import Alerts

 

Your partner in FDA Detention testing. Let's find your solution.