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  3. Compliance Actions and Activities
  4. FDA Bioresearch Monitoring Information
  5. PART IV - ANALYTICAL
  1. FDA Bioresearch Monitoring Information

PART IV - ANALYTICAL

  1. Analyzing Laboratories

    All field and headquarters laboratories.

  2. Analysis

    Samples of test or control articles, or mixtures thereof, may be submitted for a determination for identity, strength, potency, purity, or composition. Sample analysis will follow the exact methodology of the sponsor or the testing facility. If the methodology is available at the testing facility, the field investigator must submit the methodology with the sample. In those cases where a contract testing facility does not have the methodology, the field investigator should direct the facility to request the method be provided to the district laboratory by the sponsor.

  3. Identification of Appropriate District Laboratory

    Contact ORO, Division of Field Science (HFC-140) at (301) 827-7065.

  4. Reporting

    The analyzing laboratory will submit copies of the Collection Report and the Analytical Worksheets to the originating District Office and to the Center with reference to the EIR.