# FDA 483 - Iridex Corporation - September 20, 2023

Source: https://www.globalkeysolutions.net/records/483/iridex-corporation/993847e9-01f7-4291-8824-6b96a87b028d

> FDA 483 for Iridex Corporation on September 20, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Iridex Corporation
- Inspection Date: 2023-09-20
- Product Type: device
- Office Name: Division of Human and Animal Food Operations - West V
- Summary: Iridex Corporation, a medical device manufacturer in Mountain View, CA, was cited for significant deficiencies in its complaint handling, corrective and preventive action (CAPA) system, and adverse event reporting. The inspection revealed failures to investigate complaints, conduct proper complaint trending, and ensure complete and timely submission of MEDWATCH reports, indicating a systemic breakdown in quality system processes.

## Related Officers

- [Brittany D. Mccracken](https://www.globalkeysolutions.net/people/brittany-d-mccracken/a869ecee-3b7b-4c1a-8c77-7efb1a3d902a)
- [investigator](https://www.globalkeysolutions.net/people/maida-henesian/cd28e878-000c-4af8-8dbd-4863057758bb)

Company: https://www.globalkeysolutions.net/companies/iridex-corporation/9c886e2b-8873-4b61-b8b2-468461ced7a5

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-v/0f4dd01e-8e8a-4336-9abe-ce8b3d309e8b