Company
United StatesCRYON-X LLC, Shelton, CT – FDA Inspections
Inspection records and compliance data for CRYON-X LLC in Shelton, Connecticut. 1 FDA inspection on record, last inspected August 12, 2026.
Company Profile
This profile covers CRYON-X LLC based in Shelton, Connecticut, United States.
FDA Inspection History
- FDA inspections
- 1
- OAI
- 0
- VAI
- 1
- NAI
- 0
- Form 483s
- 0
- Warning letters
- 0
Inspected August 12, 2026.
Most cited issue areas
- Complaint handling procedures lack required elements1 inspection
- Corrective action procedures not documented1 inspection
- Devices subject to device identification GUDID data submission requirements.1 inspection
FDA inspections (1)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| August 12, 2026 | VAI | · Postmarket Assurance: Devices | 1330984 |
FDA documents
No Form 483s, Warning Letters or EIRs on record.
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Company Information
Name
CRYON-X LLC
FEI Number
3033648890
Address
1 Parrott Dr Ste 400, Shelton, Connecticut 06484, United States
Country
United States
ID: fb15f280-7166-4e55-8afb-b78cda7f5e10