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SRK is well aware that he has a tough task ahead of him

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 photocopies as needed, and log which documents were requested and any FDA comments

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