483
CRYON-X LLCCRYON-X LLC – FDA 483, Aug 12, 2026
Record Details
An FDA inspection of CRYON-X LLC in Shelton, CT, an initial importer and distributor of Class II medical devices, revealed significant deficiencies in their quality system. The firm lacked documented procedures for supplier control, complaint handling, and corrective actions, and failed to register Unique Device Identifiers (UDIs) for its products in the GUDID database. These issues indicate a serious lack of control over device quality and regulatory compliance.
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ID · 03682106-7aff-45b9-bb6f-0119c61ce5d6
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