FDA 483 - Brigham and Women's Hospital RDRC - September 19, 2019

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.