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Food and Drug Administration Inspections
Texas A&M will permit authorized employees of the Food
and Drug Administration, at reasonable times, and in a reasonable manner, to
inspect the Texas A&M facilities involved in the conduct or support of GLP
studies and to inspect records and specimens that are required to be maintained
in accordance with the GLP regulations.
Texas A&M will provide copies of records within the scope of the GLP regulations to an authorized employee of the FDA upon request as part of an inspection. FDA representatives will be advised of the confidential nature of GLP study data. Inspection of records and copying requirements will not apply to quality assurance records. Testing facility management will provide written certification of quality assurance inspections upon request.