Lumicell, Inc.August 18, 2023

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

View on Dashboard

Discuss this record with AI

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Lumicell, Inc.

Record Details

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.

Company: Lumicell, Inc.
Inspection Date: August 18, 2023
Product Type: Drugs
Office: Division of Northeast Imports
Person: Kent A. Conforti (issuing_officer)

Open in Dashboard

ID · f5b3a78a-440a-4113-9639-bfbd4f26acc0