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Medical Devices / Inspections and Audits

Georgia Devicemaker Cited for Written MDR Procedure

July 23, 2019
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Innomed, a Savannah, Georgia-based device manufacturer, has been hit with a Form 483 over one of its written medical device reporting (MDR) procedures.

During its March 19-21 inspection of the orthopedic devicemaker’s facility, the FDA found that one of its complaint handling procedures lacked certain requirements.

The procedure did not require the firm to determine the type of report to be submitted for a complaint — five-day or 30-day — and did not call for submitting adverse event reports within a determined amount of time.

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