FDA 483 - Advanced Engineering, Inc. - September 18, 2019
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An FDA inspection of Advanced Engineering, Inc. in Huntington, IN, a medical device manufacturer, revealed significant deficiencies in their quality system. The firm failed to adequately validate processes, lacking predetermined acceptance criteria and using inconsistent parameters. Additionally, their risk analysis was found to be inadequate, specifically regarding the failure to update a Process FMEA after a product complaint involving misassembled device components.
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