# FDA 483 - Andrew J. Wagner, M.D. - March 04, 2021

Source: https://www.keypedia.com/records/483/andrew-j-wagner-md/487651d5-e5be-4137-b089-a9d99bc9df94

> FDA 483 for Andrew J. Wagner, M.D. on March 04, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Andrew J. Wagner, M.D.
- Inspection Date: 2021-03-04
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Andrew Wagner, a clinical investigator in Boston, MA, revealed a significant issue with non-compliance to an Institutional Review Board (IRB) approved protocol. Specifically, the firm failed to adhere to the investigational plan regarding prohibited medications and procedures for a subject, without obtaining prior medical monitor approval. This indicates a serious deviation from established research guidelines.

## Related Officers

- [investigator](https://www.keypedia.com/people/jose-a-torres/0c491014-1dd0-4024-99b2-203b830b9c2b)
- [issuing_officer](https://www.keypedia.com/people/victoria-m-daddeo/f1832c5e-d242-4e1a-8c30-4c951c3976ea)

Company: https://www.keypedia.com/companies/andrew-j-wagner-md/5db8a828-7260-4c9f-9676-25f361f19f39

Office: https://www.keypedia.com/offices/division-of-northeast-imports/b20599cf-9797-41fd-947f-6589ef596a94