FDA 483 - Cryo-Dynamics, Inc. - December 04, 2025

Cryo-Dynamics, Inc., an initial importer and specification developer in Southlake, TX, was cited with five observations during an FDA inspection. The inspection revealed significant deficiencies in the firm's quality system, including inadequate procedures for corrective and preventive actions, complaint handling, and medical device reporting. Additionally, the firm failed to conduct required quality audits and validate critical software systems used in its quality processes.