483
Glaukos CorporationGlaukos Corporation – FDA 483, Apr 22, 2025
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.
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ID · 75592a62-0ccb-440f-b6e5-179b4bb122bd
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