Devices

MDR Violations at Neitz Instruments

A 5/15-5/19/23 FDA inspection at Neitz Instruments Company in Ichibancho, Japan, found Medical Device Reporting (MDR) issues in the firm’s manufacturing of the Neitz Halogen Ophthalmoscope BXa. A just-released 8/25/23 Warning Letter says Neitz failed to develop, maintain, and implement written Medical Device Reporting procedures as required by regulations.

Specifically, the letter says firm documents:

do not establish internal systems that provide for timely and effective identification, communication, and evaluation of events that may be subject to MDR requirements;
do not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under the regulations;
do not establish internal systems that provide for a standardized review process to determine when an event meets the criteria for reporting under the regulations; and
do not describe how the firm will address documentation and recordkeeping requirements.

The letter also says there is no evidence that Neitz established an active Electronic Submissions Gateway production account for the electronic submission of MDR reports.

FDA says the firm’s responses to the inspection observations were not adequate. Neitz was told to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of each action and a schedule for completing the corrections.

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