REGULATORY INTELLIGENCE·Warning Letter
FDA Recall Highlights Sterility Risks for OASIS Medical's Ophthalmic Supply Chain
OASIS Medical, Inc. has initiated a Class II recall of its "Oasis Tears PF" (Glycerin) lubricant eye drops nationwide, prompted by FDA observations regarding sterility assurance at its French manufacturer, Excelvision. This event underscores critical supply chain vulnerabilities in sterile ophthalmic products. Procurement and regulatory teams must immediately assess their reliance on contract manufacturers for sterile drug products and diversify sourcing to mitigate sterility-related recall risks.
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