483
The Morel Company, LLCThe Morel Company, LLC – FDA 483, Nov 1, 2018
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.
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ID · 0b2ffcde-c75d-4048-b981-d451a503d033
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