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FDA Inspection
•Glaukos Corporation•April 22, 2025

Glaukos Corporation – FDA Inspection, Apr 22, 2025

Record Details

This FDA Inspection record concerns Glaukos Corporation, with an inspection on April 22, 2025, issued by the Los Angeles District Office, covering human drugs.

Company
Glaukos Corporation
Inspection Date
April 22, 2025
Product Type
Human Drugs
Office
Los Angeles District Office
People
  • Joey V. Quitania (FDA Associated Person)
  • Youkeun Kim
View Company Profile

ID · 1b4713bf-a869-4279-8c47-8e76dc9f26ea

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1267669
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued, view the record

FDA Citations

1
  1. 21 CFR 211.192Investigations of discrepancies, failures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Glaukos Corporation

7
DateClassificationOfficeProject area
August 15, 2024NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
July 19, 2023Not classifiedLos Angeles District Office
August 3, 2018NAICenter for Devices and Radiological HealthBioresearch Monitoring
June 10, 2016VAICenter for Devices and Radiological HealthCompliance: Devices
June 11, 2013NAICenter for Devices and Radiological HealthBioresearch Monitoring
View all 7 other inspections on the company page
Other documents for Glaukos Corporation
  • FDA Inspection 1251714 - 2024-08-15
  • FDA Inspection 1211136 - 2023-07-19
  • FDA Inspection 1068254 - 2018-08-03
  • FDA Inspection 981961 - 2016-06-10
  • FDA Inspection 835427 - 2013-06-11

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Contact
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