Glaukos Corporation – FDA EIR, Jul 19, 2023

An FDA Pre-Approval Inspection (PAI) was conducted at Glaukos Corp. in San Clemente, CA, from July 10-19, 2023. This inspection, the firm's first drug inspection, evaluated readiness for commercial manufacturing, conformance to the application, data integrity, and commitment to quality in pharmaceutical development, aligning with CPGM 7346.832. While no FDA Form 483 was issued, four verbal observations were discussed with management.

Key findings and issues included a recommendation to enhance disinfectant efficacy qualification by explicitly incorporating non-micro flora identified during environmental monitoring and testing on all relevant surface materials, such as operators' gloves. Several non-conformance reports highlighted procedural gaps: analytical balance calibration procedures did not consistently adhere to USP<41> for minimum weight and operational range, prompting a Corrective and Preventive Action (CAPA) to revise procedures. Another CAPA was initiated to improve the evaluation and reconciliation of balance logbooks after errors in recording significant figures were found. An external notification regarding an incorrect USP reference standard value necessitated an impact analysis and revision of Certificates of Analysis. Additionally, environmental monitoring excursions, attributed to a fire sprinkler system leak and incorrect disinfectant dilution by a contractor, led to immediate remediation, including repairs, enhanced cleaning, additional monitoring, and personnel re-training in cleanroom best practices.