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•United States

Cryo-Dynamics, Inc., Southlake, TX – FDA Inspections

Inspection records and compliance data for Cryo-Dynamics, Inc. in Southlake, Texas. 1 FDA inspection on record, 1 Form 483, last inspected December 04, 2025.

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Company Profile

This profile covers Cryo-Dynamics, Inc. based in Southlake, Texas, United States.

FDA Inspection History

FDA inspections
1
OAI
0
VAI
1
NAI
0
Form 483s
1
Warning letters
0

Inspected December 4, 2025.

Most cited issue areas

  • Documentation of software validation1 inspection
  • Lack of or inadequate complaint procedures1 inspection
  • Lack of or inadequate procedures1 inspection

FDA inspections (1)

DateResultFDA center(s)Insp. #
December 4, 2025VAIMedical Devices & Rad Health · Compliance: Medical Devices1293926
FDA documents

Form 483s (1)

  • Form 483s · December 4, 2025
People (1)
Elizabeth A. Krolczyk
Person
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KENERIC HEALTHCARE
Company Information

Name

Cryo-Dynamics, Inc.

FEI Number

3030478415

Address

910 S Kimball Ave # 100, Southlake, Texas 76092, United States

Country

United States

ID: 71bef91f-f582-4cf3-937a-470799bcf9c8

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