Big News: FDA is moving from MasterControl to ComplianceQuest.See Why
Talk to a SpecialistLoading…
Talk to a SpecialistTalk to a SpecialistOasis Medical, Inc. was cited for significant Current Good Manufacturing Practice (CGMP) violations in the production of sterile ophthalmic drug products, rendering their finished pharmaceuticals adulterated. During a January 2025 inspection, the FDA found that the company failed to establish adequate written procedures for production and process control, lacked reproducible manufacturing processes, and distributed batches with excessive defect rates—including recurring visible particulate contamination levels that far exceeded acceptable standards. The company's manufacturing operations lacked an ongoing program to monitor process control and ensure consistent drug quality, resulting in a substantial portion of batches being rejected or distributed despite very high defect levels.