# FDA 483 - Alcon Research, LLC - April 25, 2023

Source: https://www.keypedia.com/records/483/alcon-research-llc/e34ae4f6-4105-4e62-9e05-71d5540be3f3

> FDA 483 for Alcon Research, LLC on April 25, 2023. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Alcon Research, LLC
- Inspection Date: 2023-04-25
- Product Type: device
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Alcon Research, LLC in Irvine, CA, a medical device manufacturer, identified a significant deficiency in their corrective and preventive action (CAPA) system. The firm closed a CAPA related to nonconforming raw material (flash drive data for a component) without conducting an effectiveness check or verifying that the corrective action adequately addressed the root cause. This lapse is concerning as the risk management report indicates a possible patient risk of retinal detachment.

## Related Documents

- [483 - 2019-12-05](https://www.keypedia.com/records/483/alcon-research-llc/c7dfc5e9-7d09-4814-93be-83399c411712)

## Related Officers

- [Marlo-Ian M. Alintanahin](https://www.keypedia.com/people/marlo-ian-m-alintanahin/a37da927-b369-4753-b275-41743556f25e)

Company: https://www.keypedia.com/companies/alcon-research-llc/3f7b4901-5f9f-4d4c-96ec-703f2ef5285b

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6