Overview
- 3 FDA inspections are on record.
- 3 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-03-26.
At a glance
Inspections
3
Form 483s
3
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 23 Mar 2026 – 26 Mar 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 18 Jul 2023 – 21 Jul 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Jul 2019 – 25 Jul 2019 | Medical Devices & Rad Health | 483 | On file |
Observations on record
Form 483 observations cited at this site, most recent first.
26 Mar 2026
ISO 13485:2016 Clause 7.5.6
Procedures for validation of processes not documented
Cited by Tiki Dixon
26 Mar 2026
ISO 13485:2016 Clause 7.5.7
Processes for sterilization and sterile barrier systems not validated
Cited by Tiki Dixon
21 Jul 2023
21 CFR 820.75(b)
Lack/Inad procedure-Monitoring/Control of Validated Proces
Cited by Christina L Bigham
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 820.75(a) | Cited across public-safe Form 483 observations | 1x |
| 21 CFR 820.75(b) | 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 7.5.7 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind SM ENG. Co. Ltd.'s 3 Form 483s
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