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Some common documents that are initially requested include the following: Organization charts indicating key personnel Facility floor plan Product list Manufacturing process diagram and flowchart Equipment list (Production and Laboratory) SOP index Document control and retrieval is one of the most critical aspects of managing an FDA inspection, so it is a good idea to assign an additional employee to the FDA inspection team as the runner who will retrieve additional requested documentation, make copies as needed, and log which documents were requested and any FDA comments

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Makes technical amendments to administrative provisions of the JJDPA, adding requirements relating to withholding of funds, use of funds, payments, and confidentiality of program records