Glaukos CorporationApril 22, 2025

FDA 483 - Glaukos Corporation - April 22, 2025

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Record Details

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.

Company: Glaukos Corporation
Inspection Date: April 22, 2025
Product Type: Drugs
Office: Los Angeles District Office
People: Youkeun Kim
Joey V. Quitania (Public Affairs Specialist)

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ID · 75592a62-0ccb-440f-b6e5-179b4bb122bd