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.
- Company
- CRYON-X LLC
- Inspection Date
- August 12, 2026
- Product Type
- Devices
View Company Profile
ID · 2193b293-e47d-4791-8135-f2b4b19c537f
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1330984
- Project area
- Postmarket Assurance: Devices
FDA Citations
4- 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
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