FDA Inspection
Sciteck DiagnosticsSciteck Diagnostics – FDA Inspection, Aug 3, 2018
Record Details
This FDA Inspection record concerns Sciteck Diagnostics, with an inspection on August 3, 2018, issued by the Center for Devices and Radiological Health, covering devices.
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ID · cfb96b39-37c8-4167-adc4-7b9d62fdc54e
Inspection Facts
No Action Indicated (NAI)
No objectionable conditions or practices were found during the inspection.
- Inspection number
- 1060965
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.120(b)DHR documentation of label release {see also 820.184}
- 21 CFR 820.120(d)Records, DHR {see also 820.184(e)}
- 21 CFR 820.180Availability
- 21 CFR 820.30(a)Design control - no procedures
- 21 CFR 820.40(a)Not approved or obsolete document retrieval
- 21 CFR 820.70(g)(1)Maintenance schedule, Lack of or inadequate schedule
- 21 CFR 820.72(b)Calibration procedures - content
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Other FDA inspections of Sciteck Diagnostics
1| Date | Classification | Office | Project area |
|---|---|---|---|
| June 3, 2026 | NAI | Atlanta District Office | Postmarket Assurance: Devices |
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