Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-02-06.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 2 Feb 2026 – 6 Feb 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 14 Nov 2022 – 15 Nov 2022 | Medical Devices & Rad Health | Clean | |
| 31 Oct 2017 – 3 Nov 2017 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
6 Feb 2026
21 CFR 820.35(a)
Records for complaints involving failure to meet specifications not maintained
Cited by Edward E Lockwood
6 Feb 2026
ISO 13485:2016 Clause 7.1
Required elements not determined in planning product realization
Cited by Edward E Lockwood
6 Feb 2026
ISO 13485:2016 Clause 7.3.9
Significance of design and development changes not determined
Cited by Edward E Lockwood
6 Feb 2026
ISO 13485:2016 Clause 7.4.1
Criteria for the evaluation and selection of suppliers not established
Cited by Edward E Lockwood
Investigators
FDA investigators tied to this site in the record.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 820.30(i) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.35(a) | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.3.9 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Koven Technology, Inc.'s 2 Form 483s
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