Glaukos Corporation
Form 483 issued April 22, 2025 · San Clemente, California
- Inspection
- Apr 14 – Apr 22, 2025
- Observations
- 1
- Pages
- 3
- FEI number
- 3012341472
In short: On April 22, 2025, FDA issued a Form 483 with 1 observation to Glaukos Corporation in San Clemente, California (FEI 3012341472) after an inspection that ran Apr 14 – Apr 22, 2025. Most observations concern quality system; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
This inspection in context
Questions about this 483
What did FDA find at Glaukos Corporation?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
When was Glaukos Corporation inspected by FDA?
The inspection ran Apr 14 – Apr 22, 2025, and the Form 483 is dated April 22, 2025.
How do I get the full Form 483 for Glaukos Corporation?
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