FDA Inspection 1320280 — Sciteck Diagnostics
The FDA completed an inspection of Sciteck Diagnostics on June 3, 2026 in Fletcher, NC. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- Voluntary Action Indicated (VAI) (VAI)
- End Date
- June 3, 2026
- Fiscal Year
- 2026
- Product Type
- Devices
- Project Area
- Compliance: Devices
- Location
- Fletcher, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 23038 | ISO 13485:2016 Clause 4.2.4 | Lack of document control |
| 23156 | ISO 13485:2016 Clause 7.5.1 | Production controls not adequate |
| 23233 | ISO 13485:2016 Clause 8.2.6 | Test equipment for measurement activities not recorded |