FDA WARNING_LETTER - Neitz Instruments Company Ltd. - May 19, 2023

On August 25, 2023, the FDA issued a Warning Letter to a firm in Ichibancho, Japan, following an inspection from May 15-19, 2023. The firm manufactures the Neitz Halogen Ophthalmoscope BXa, 13A, which are medical devices. The inspection revealed the devices are misbranded under section 502(t)(2) of the Act, due to the firm's failure to furnish required material or information under section 519 of the Act and 21 CFR Part 803 - Medical Device Reporting (MDR).

Significant violations include the failure to develop, maintain, and implement written MDR procedures as required by 21 CFR 803.17. Specifically, the firm's procedures lacked: 1. Internal systems for timely identification, communication, and evaluation of events subject to MDR, including definitions for reportable events (e.g., "serious injury," "malfunction") and instructions for timely evaluation. 2. A standardized review process for determining when an event meets reporting criteria, including instructions for investigating reportable events and identifying who makes reporting decisions. 3. Internal systems for timely transmission of complete MDRs, such as instructions for completing FDA Form 3500A, circumstances for submitting various report types (30-day, 5-day, follow-up), and a process for