483
3D Imaging Drug Design and Development3D Imaging Drug Design and Development – FDA 483, Jan 31, 2024
Record Details
An FDA inspection of 3D Imaging Drug Design and Development, a PET Drug Producer in Little Rock, AR, revealed significant deficiencies in their written procedures. The firm lacked adequate procedures for the receipt, evaluation, and reporting of post-marketing adverse drug experiences, as well as for the correct retention timeframe of drug product complaint records. These issues indicate a failure to establish proper controls for drug safety reporting and complaint handling.
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ID · b21c2326-aca9-4c9b-861d-baa1a8c486b6
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