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U.S. Department of Health and Human Services

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66. FDA Draft Records Access Guidance: How Will FDA Make a Request?

Overview of Bioterrorism Act Establishment and Maintenance of Records Final Rule

January 2005

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FDA Draft Records Access Guidance: How Will FDA Make a Request? - see text below

FDA Draft Records Access Guidance:
How Will FDA Make a Request?

  • An investigator or other FDA personnel upon presentation of credentials will submit a written notice, FDA 482 – Notice of Inspection, to the owner, operator, or agent in charge, and inform that person of the records requested and FDA’s legal authority to obtain these records.
    • Note: FDA may request additional records related to the implicated food article at a later time under the same authority.
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