FDA Inspection
CRYON-X LLCCRYON-X LLC – FDA Inspection, Aug 12, 2026
Record Details
This FDA Inspection record concerns CRYON-X LLC, with an inspection on August 12, 2026, issued by the Center for Devices and Radiological Health, covering devices.
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ID · b17e699e-f0e8-45d4-8170-b6e3fe36f6c5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1330984
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
6- ISO 13485:2016 Clause 8.5.2Corrective action procedures not documented
- 21 CFR 830Devices subject to device identification GUDID data submission requirements.
- ISO 13485:2016 Clause 8.2.2Complaint handling procedures lack required elements
- ISO 13485:2016 Clause 7.1Procedures for purchasing process not documented
- 21 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
- ISO 13485:2016 Clause 7.4.1Procedures for purchasing process not documented
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