# FDA 483 - Lumicell, Inc. - August 18, 2023

Source: https://www.keypedia.com/records/483/lumicell-inc/f5b3a78a-440a-4113-9639-bfbd4f26acc0

> FDA 483 for Lumicell, Inc. on August 18, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Lumicell, Inc.
- Inspection Date: 2023-08-18
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: Lumicell, Inc. in Newton, MA, was inspected from August 14-18, 2023, regarding an investigational study. The inspection revealed that proper monitoring of the study was not ensured, including incomplete reports and follow-up letters for site visits. Additionally, a medical monitoring plan was not established until several months after subjects began receiving injections, indicating a significant lapse in clinical trial oversight.

## Related Officers

- [issuing_officer](https://www.keypedia.com/people/kent-a-conforti/8d3d3e82-cd97-420e-8840-df92d6eeba09)

Company: https://www.keypedia.com/companies/lumicell-inc/89f28fd8-1dfb-4e87-8b06-04d142447550

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