FDA 483 - Quicksilver Scientific - September 21, 2023

An FDA inspection of Quicksilver Scientific in Louisville, CO, a manufacturer of blood testing kits, revealed significant deficiencies in their quality system for medical devices. The firm failed to adequately establish and follow procedures for device control, distribution, and acceptance activities. Furthermore, the company did not maintain required device master records, device history records, or documentation for supplier evaluations, indicating a broad lack of compliance with medical device regulations.