# FDA 483 - Andrew A. Nierenberg, M.D. - February 21, 2020

Source: https://www.keypedia.com/records/483/andrew-a-nierenberg-md/a9fc05a8-51c6-417f-9513-e1862fd79337

> FDA 483 for Andrew A. Nierenberg, M.D. on February 21, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Andrew A. Nierenberg, M.D.
- Inspection Date: 2020-02-21
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Andrew A. Nierenberg, M.D. in Boston, MA, identified significant deficiencies in the conduct of two clinical trials. The inspection revealed failures in monitoring study progress, maintaining adequate case histories, and adhering to the investigational plan and protocol. These issues indicate a lack of proper oversight and documentation in clinical research.

## Related Officers

- [Matthew C. Watson](https://www.keypedia.com/people/matthew-c-watson/a1594b84-f65a-42f9-a06d-a68a49eb4b28)

Company: https://www.keypedia.com/companies/andrew-a-nierenberg-md/d99655e8-cc3b-4a03-ab68-c4eaa7ba8253

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