# FDA 483 - Aldeyra Therapeutics, Inc. - April 28, 2023

Source: https://www.keypedia.com/records/483/aldeyra-therapeutics-inc/17609cac-2c9d-48d0-a5ba-e10366decded

> FDA 483 for Aldeyra Therapeutics, Inc. on April 28, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Aldeyra Therapeutics, Inc.
- Inspection Date: 2023-04-28
- Product Type: drugs
- Office Name: Division of Northeast Imports 
- Summary: An FDA inspection of Aldeyra Therapeutics, Inc. in Lexington, MA, a sponsor of clinical studies, revealed a significant failure in ensuring proper monitoring of a study. Specifically, the monitor failed to identify multiple discrepancies where Multi-Symptom Visual Analog Scale (VAS) scores were incorrectly measured and reported in the electronic data capture system for several subjects. This indicates issues with data integrity and oversight in their clinical trial processes.

## Related Documents

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## Related Officers

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

Company: https://www.keypedia.com/companies/aldeyra-therapeutics-inc/1a871130-ca82-4441-a7a4-7d7c28561ffa

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