483
Poiesis Medical, LLCFDA 483 - Poiesis Medical, LLC - October 30, 2024
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Record Details
An FDA inspection of Poiesis Medical, LLC in Jupiter, FL, identified a significant lapse in quality system management. The firm failed to conduct and document required management reviews of its quality system at defined intervals, as stipulated by its own procedures. This indicates a fundamental issue with oversight of the quality system's suitability and effectiveness.
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