The Morel Company, LLCNovember 1, 2018

FDA 483 - The Morel Company, LLC - November 01, 2018

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Record Details

An FDA inspection of The Morel Company, LLC, a medical device manufacturer in Batesville, IN, identified a repeat observation regarding inadequate procedures for the rework of nonconforming products. Specifically, the firm failed to document adverse impact assessments in device history records after rework and re-evaluation activities. This indicates a persistent issue with quality system controls.

Company: The Morel Company, LLC
Inspection Date: November 1, 2018
Product Type: Device
Office: Division of Pharmaceutical Quality Operations III
Person: Teresa Kastner (Consumer Safety Officer, Medical Device Specialist)

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ID · 0b2ffcde-c75d-4048-b981-d451a503d033