# FDA 483 - Deepak C. D'Souza, M.D. - May 20, 2022

Source: https://www.keypedia.com/records/483/deepak-c-dsouza-md/af2bccd7-587c-42b6-9aa2-3b5df081ca43

> FDA 483 for Deepak C. D'Souza, M.D. on May 20, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Deepak C. D'Souza, M.D.
- Inspection Date: 2022-05-20
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Deepak C. D'Souza, M.D., a Sponsor-Investigator, was cited for failing to conduct a clinical investigation in accordance with the signed statement of investigator and investigational plan. A serious adverse event (SAE) involving hypotension and bradycardia was not identified and reported to the Human Studies Subcommittee and FDA in a timely manner. This constitutes a significant violation of 21 CFR 312.64 regarding investigator responsibilities for reporting adverse events.

## Related Officers

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

Company: https://www.keypedia.com/companies/deepak-c-dsouza-md/aa2741cf-0312-48b3-ba0c-f72be6c0c828

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