# FDA 483 - Glaukos Corporation - April 22, 2025

Source: https://www.globalkeysolutions.net/records/483/glaukos-corporation/75592a62-0ccb-440f-b6e5-179b4bb122bd

> FDA 483 for Glaukos Corporation on April 22, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Glaukos Corporation
- Inspection Date: 2025-04-22
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: An FDA inspection of Glaukos Corporation in San Clemente, CA, a manufacturer of combo drug/device intracameral implants, identified one observation. The firm failed to thoroughly review an unexplained discrepancy involving foreign material found during the filling of their iDose product. This indicates a lapse in quality system procedures for investigating product issues.

## Related Documents

- [EIR - 2023-07-19](https://www.globalkeysolutions.net/records/eir/glaukos-corporation/5fa46de4-6b74-433c-9f93-15d891285975)

## Related Officers

- [Youkeun Kim](https://www.globalkeysolutions.net/people/youkeun-kim/94ccfde4-72f7-4df1-9c68-ede73e5e23d0)
- [Public Affairs Specialist](https://www.globalkeysolutions.net/people/joey-v-quitania/faae874f-94ea-4b63-89d1-649e60726f6f)

Company: https://www.globalkeysolutions.net/companies/glaukos-corporation/9e9a7fd4-2158-4073-b5b9-79ba4fbdde83

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b