483
Pure Source LLCPure Source LLC – FDA 483, Jul 28, 2026
Record Details
An FDA inspection of Pure Source, LLC, a medical device contract manufacturer in Doral, FL, revealed significant deficiencies in their risk management record-keeping. The firm failed to adequately maintain records for hazard identification, product risk assessments, and the incorporation of post-market feedback, specifically concerning particulate matter in their manufactured devices. These issues indicate a serious lapse in their quality system regarding risk management processes.
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- Florida District Office
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ID · 08b700e8-c431-42aa-8f20-b470c02387fb
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