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Talk to a SpecialistTalk to a SpecialistNeitz Instruments Company Ltd., a Japanese manufacturer of the Neitz Halogen Ophthalmoscope BXa, was cited for misbranding violations under the Federal Food, Drug, and Cosmetic Act due to failure to comply with Medical Device Reporting (MDR) requirements. An FDA inspection conducted May 15-19, 2023, found that the company failed to develop, maintain, and implement adequate written MDR procedures as required by 21 CFR 803.17, specifically lacking internal systems to timely identify, communicate, and evaluate adverse events subject to MDR reporting. The company's existing complaint handling, post-market safety control, corrective action, and recall procedures were determined to be insufficient and did not meet FDA regulatory requirements for device safety monitoring and reporting.