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June xx, 2013 URGENT FIELD SAFETY NOTICE Inspection of ORT HO Biome System Cassettes Dear Customer, As part of a Field Safety Corrective Action, this notification provides information that Or tho
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Inspection of Ortho Biovue is a regulatory requirement to ensure compliance with medical device regulations.
Manufacturers and distributors of Ortho Biovue devices are required to file the inspection.
The inspection of Ortho Biovue can be filled out online through the designated regulatory platform.
The purpose of inspection of Ortho Biovue is to ensure the safety and effectiveness of the medical device.
The inspection report must include details of manufacturing processes, quality control measures, and adverse event reporting.
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