Overview
- 4 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-05-01.
At a glance
Inspections
4
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 28 Apr 2026 – 1 May 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 4 Jan 2017 – 9 Jan 2017 | Medical Devices & Rad Health | Clean | |
| 19 Dec 2013 – 26 Dec 2013 | Medical Devices & Rad Health | Clean | |
| 22 Jun 2011 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
1 May 2026
ISO 13485:2016 Clause 4.1.5
Control over outsourced processes not proportionate to risk
Cited by Javonica F Penn
1 May 2026
ISO 13485:2016 Clause 4.1.5
Control over outsourced processes not proportionate to risk
Cited by Javonica F Penn
1 May 2026
ISO 13485:2016 Clause 8.2.2
Complaint handling procedures not documented
Cited by Javonica F Penn
1 May 2026
ISO 13485:2016 Clause 8.2.2
Complaint handling procedures not documented
Cited by Javonica F Penn
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 |
|---|---|---|
| ISO 13485:2016 Clause 4.1.5 | Cited across public-safe Form 483 observations | 2x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Lumitex Medical Devices Inc's 1 Form 483
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