Drug factory · FDA FEI 3012341472
Glaukos Corporation
229, 236 Avenida Fabricante, San Clemente, CA, United States
Problems found, fixed voluntarily at FDA's last inspection, Apr 22, 2025.
Voluntary Action Indicated: inspectors found problems, but not serious enough for FDA to take action. The company is expected to fix them.
2 drug inspections on record since 2024: 1 with no problems, 1 with problems fixed voluntarily, 0 with FDA action.
What it does, for whom
| Drug | Role | For | NDC |
|---|---|---|---|
| Travoprost | Makes it, tests it, packages it and labels it | Glaukos Corporation | 25357-100 |
FDA inspection history
| Ended | Result | Program | Problems noted |
|---|---|---|---|
| Apr 22, 2025 | Problems found, fixed voluntarily | Drug Quality Assurance | 1 |
| Aug 15, 2024 | No problems found | Bioresearch Monitoring | — |
What inspectors wrote down
From FDA's Form 483 citations: conditions an investigator observed that may violate drug manufacturing rules, as FDA published them.
Apr 22, 2025 inspection
- Investigations of discrepancies, failures 21 CFR 211.192
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.
Registered with FDA for: analysis; label; manufacture; pack.