# CRYON-X LLC – FDA 483, Aug 12, 2026

Source: https://www.keypedia.com/records/483/cryon-x-llc/03682106-7aff-45b9-bb6f-0119c61ce5d6

> FDA 483 for CRYON-X LLC on August 12, 2026. Product: device. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: CRYON-X LLC
- Inspection Date: 2026-08-12
- Product Type: device
- Office Name: Center for Devices and Radiological Health
- Summary: 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.

## Related Officers

- [Katarzyna Plona](https://www.keypedia.com/people/katarzyna-plona/ea20d6c6-5d2d-41a0-a755-0647fb9f3250)

Company: https://www.keypedia.com/companies/cryon-x-llc/fb15f280-7166-4e55-8afb-b78cda7f5e10

Office: https://www.keypedia.com/offices/center-for-devices-and-radiological-health/9d89aff6-e435-4764-87be-f58c01aca7f7