Overview
- 1 FDA inspection is on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-05-07.
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 |
|---|---|---|---|
| 4 May 2026 – 7 May 2026 | Medical Devices & Rad Health | 483 | View 483 → |
Observations on record
Form 483 observations cited at this site, most recent first.
7 May 2026
21 CFR 830.300(a)
Devices subject to device identification GUDID data submission requirements.
Cited by Elizabeth A Krolczyk
7 May 2026
ISO 13485:2016 Clause 4.1.6
QMS software not validated prior to use or changes
Cited by Elizabeth A Krolczyk
7 May 2026
ISO 13485:2016 Clause 4.2.3
Medical device file does not contain specific requirements
Cited by Elizabeth A Krolczyk
7 May 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
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 830.300(a) | 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 4.2.3 | 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 7.5.6 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.2.1 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind BNX Converting, LLC'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