# FDA 483 - Andrea J. Bullock, MD - October 06, 2021

Source: https://www.globalkeysolutions.net/records/483/andrea-j-bullock-md/a2b4b501-fda8-43dd-bda6-1a0d0cdfdfe3

> FDA 483 for Andrea J. Bullock, MD on October 06, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Andrea J. Bullock, MD
- Inspection Date: 2021-10-06
- Product Type: drugs
- Office Name: FDA District Office — Stoneham, Massachusetts
- Summary: Andrea J. Bullock, M.D. Clinical Investigator in Boston, MA, received a Form 483 citing two significant observations during an FDA inspection. The firm failed to conduct an investigation according to its investigational plan, including enrolling an ineligible subject and not timely reporting a serious adverse event. Additionally, records for adverse device effects were found to be inaccurate, incomplete, and not current, with eCRF updates lacking supporting source documentation.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/victoria-m-daddeo/f1832c5e-d242-4e1a-8c30-4c951c3976ea)
- [issuing_officer](https://www.globalkeysolutions.net/people/alicia-dalley/8c798f2e-ad71-4e5a-a69a-265f6dbb9c1c)

Company: https://www.globalkeysolutions.net/companies/andrea-j-bullock-md/b25d3df4-b25b-4a61-9e4c-f1767e4fc68a

Office: https://www.globalkeysolutions.net/offices/fda-district-office-stoneham-massachusetts/1daceb4f-4057-46cf-af02-d4ccde44dcc7