OMIC USA, Inc.

Import

      The Food and Drug Administration (FDA) has for many years used private testing laboratories in determining the quality of foodstuffs imported into the United States. The FDA estimates that importers have used over 100 private laboratories to generate analytical data in support of claims that imported food products comply with U.S. laws.

      OMIC USA, Inc.'s laboratory is one of the forefront laboratories in dealing with the FDA and working with their programs such as automatic detentions program.

      The Code of Federal Register (CFR) #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.

      For your information we have provided an overview of the requirements.

Sample Collection

      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.

Analytical Report

      All reports we submit to the FDA contain a minimum of the following:


• Sample Collection Report (must be on file with the FDA)
• Analytical worksheets for sample preparation, extraction method, instrumentation, calibration, and calculation.
• Preparation of analytical standards including the purity and the source.
• All chromatograms and/or spectra.
• Curriculum Vitae of personnel.
• A list of equipment used for conducting the analysis and their calibration status.
• Updated quality control records.