483
SYNAPTIC MEDICAL CORPORATIONFDA 483 - SYNAPTIC MEDICAL CORPORATION - March 31, 2026
Record Details
An FDA inspection of Synaptic Medical Corporation in Carlsbad, CA, identified a significant issue regarding the monitoring of an investigational study. The firm failed to ensure proper monitoring, specifically concerning subject eligibility criteria for a protocol, leading to the enrollment of ineligible subjects. This indicates a lapse in clinical trial oversight and adherence to their own monitoring plan.
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ID · 8a444134-4b4b-4c40-9708-25d8683dfc25
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