483
Vortex Surgical Inc.Vortex Surgical Inc. – FDA 483, Jan 8, 2026
Record Details
Vortex Surgical Inc. in Saint Charles, MO, was inspected from January 6-8, 2026, and received one observation. The firm failed to adequately control nonconforming products, specifically Class II laser probes that were part of a recall, by improperly storing them without proper identification or adherence to company procedures and FDA commitments. This indicates a significant lapse in quality control for medical devices.
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