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37 FDA personnelupon presenting appropriate credentials and a written notice to the owner, operator, or agent in chargeare authorized to enter the tobacco product manufacturer to inspect the factory and all pertinent equipment and materials "at reasonable times and within reasonable limits and in a reasonable manner." 38 Upon completing the inspection and prior to leaving the premises, FDA is required to produce a written report describing any observed conditions or practices indicating that any tobacco product has been prepared in a way that is injurious to health

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