FDA Inspection 1330984 — CRYON-X LLC
The FDA completed an inspection of CRYON-X LLC on Aug 12, 2026 in Shelton, CT. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action). 4 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI)
- End Date
- Aug 12, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Shelton, CT (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 22800 | 21 CFR 830.300(a) | Devices subject to device identification GUDID data submission requirements. |
| 23138 | ISO 13485:2016 Clause 7.4.1 | Procedures for purchasing process not documented |
| 23215 | ISO 13485:2016 Clause 8.2.2 | Complaint handling procedures lack required elements |
| 23258 | ISO 13485:2016 Clause 8.5.2 | Corrective action procedures not documented |