Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-04-24.
At a glance
Inspections
1
Form 483s
1
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 22 Apr 2026 – 24 Apr 2026 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
24 Apr 2026
ISO 13485:2016 Clause 4.1.2
Risk-based approach not applied to QMS processes
Cited by Elizabeth A Krolczyk
24 Apr 2026
ISO 13485:2016 Clause 4.1.6
QMS software not validated prior to use or changes
Cited by Elizabeth A Krolczyk
24 Apr 2026
ISO 13485:2016 Clause 4.2.1
Quality management system documentation not adequate
Cited by Elizabeth A Krolczyk
Investigators
FDA investigators tied to this site in the record.
Elizabeth A Krolczyk1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 801.20(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 803.17 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.1.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.1.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 4.2.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 5.6.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 6.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 7.4.1 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.4 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.3 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Emerge Technologies 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