Overview
- 5 FDA inspections are on record.
- 1 inspection produced a Form 483.
- The most recent recorded inspection date is 2026-02-06.
At a glance
Inspections
5
Form 483s
1
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 4 Feb 2026 – 6 Feb 2026 | Medical Devices & Rad Health | Clean | |
| 21 Mar 2022 – 25 Mar 2022 | Medical Devices & Rad Health | 483 | View 483 → |
| 5 Mar 2018 – 7 Mar 2018 | Medical Devices & Rad Health | Clean | |
| 15 Mar 2015 – 16 Mar 2015 | Medical Devices & Rad Health | Clean | |
| 14 Mar 2015 – 15 Mar 2015 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
25 Mar 2022
21 CFR 820.198(c)
Investigation of device failures
Cited by Adaliz Santaliz-Cruz, Gamal A Norton
25 Mar 2022
21 CFR 820.90(b)(2)
Product rework procedures, Lack of or inadequate procedures
Cited by Adaliz Santaliz-Cruz, Gamal A Norton
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 820.100(b) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.120(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.198(c) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.90(b)(2) | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Safeguard US Operating LLC's 1 Form 483
Source PDFs 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