FDA Inspection 1060965 — Sciteck Diagnostics
The FDA completed an inspection of Sciteck Diagnostics on August 3, 2018 in Fletcher, NC. The inspection was classified NAI (No Action Indicated — no objectionable conditions were found). 7 citations were issued during this inspection. Product area: Devices.
Inspection Details
- Classification
- No Action Indicated (NAI) (NAI)
- End Date
- August 3, 2018
- Fiscal Year
- 2018
- Product Type
- Devices
- Project Area
- Postmarket Assurance: Devices
- Location
- Fletcher, NC (United States)
Citations
| ID | CFR | Description |
|---|---|---|
| 2371 | 21 CFR 820.30(a) | Design control - no procedures |
| 3149 | 21 CFR 820.180 | Availability |
| 3201 | 21 CFR 820.40(a) | Not approved or obsolete document retrieval |
| 3226 | 21 CFR 820.70(g)(1) | Maintenance schedule, Lack of or inadequate schedule |
| 3236 | 21 CFR 820.72(b) | Calibration procedures - content |
| 3310 | 21 CFR 820.120(b) | DHR documentation of label release {see also 820.184} |
| 3313 | 21 CFR 820.120(d) | Records, DHR {see also 820.184(e)} |