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

Source: https://www.globalkeysolutions.net/records/483/brigham-and-womens-hospital-rdrc/640fc084-e63f-4bf7-ac19-5925a751e988

> FDA 483 for Brigham and Women's Hospital RDRC on September 19, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Brigham and Women's Hospital RDRC
- Inspection Date: 2019-09-19
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: 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.

## Related Officers

- [investigator](https://www.globalkeysolutions.net/people/geoffrey-k-kilili/b00aeedf-95bd-4ccf-a23e-6e12e60249c4)

Company: https://www.globalkeysolutions.net/companies/brigham-and-womens-hospital-rdrc/fb2e3fce-59df-4f4c-89f2-e1570433b874

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22