483
Brigham and Women's Hospital RDRCBrigham and Women's Hospital RDRC – FDA 483, Sep 19, 2019
Record Details
This FDA Form 483 details observations made at Brigham and Women's Hospital RDRC in Boston, MA, during an inspection from September 16-19, 2019. The inspection revealed multiple deficiencies primarily related to the labeling of radioactive drugs for research use and record-keeping practices of the Radioactive Drug Research Committee. These issues indicate a lack of adherence to regulatory requirements for radioactive drug research.
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