Overview
- 2 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-03.
At a glance
Inspections
2
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Jun 2026 – 3 Jun 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 1 Aug 2018 – 3 Aug 2018 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
3 Jun 2026
ISO 13485:2016 Clause 8.2.6
Test equipment for measurement activities not recorded
Cited by Benjamin E Bowen
3 Aug 2018
21 CFR 820.120(b)
DHR documentation of label release {see also 820.184}
Cited by Gamal A Norton
3 Aug 2018
21 CFR 820.120(b)
DHR documentation of label release {see also 820.184}
Cited by Gamal A Norton
Investigators
FDA investigators tied to this site in the record.
Benjamin E Bowen1 insp.
Gamal A Norton1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.120(b) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.120(d) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.180 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.40(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.70(g)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.72(b) | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 4.2.4 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.5.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.6 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sciteck Diagnostics' 2 Form 483s
Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.
- The site's full inspection history, with every Form 483 and its outcome
- Warning letters and recalls tied to the company behind it
- Whether recurring CFR citations get closed out or repeat