Overview
- 3 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-05-28.
At a glance
Inspections
3
Form 483s
2
EIRs
0
Last outcome
Form 483
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 25 May 2026 – 28 May 2026 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Sep 2023 – 14 Sep 2023 | Medical Devices & Rad Health | 483 | View 483 → |
| 22 Sep 2014 – 25 Sep 2014 | Medical Devices & Rad Health | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
28 May 2026
ISO 13485:2016 Clause 7.1
Product realization risk management processes not documented
Cited by Joshua J Silvestri
28 May 2026
ISO 13485:2016 Clause 7.4.3
Purchased product verification activities are inadequate
Cited by Joshua J Silvestri
28 May 2026
ISO 13485:2016 Clause 8.4
Procedures for data analysis do not include determination of appropriate methods
Cited by Joshua J Silvestri
28 May 2026
ISO 13485:2016 Clause 8.4
Records of data analysis results not maintained
Cited by Joshua J Silvestri
28 May 2026
ISO 13485:2016 Clause 8.5.2
Corrective action procedures not documented
Cited by Joshua J Silvestri
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 8.4 | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.90(a) | 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 7.4.3 | Cited across public-safe Form 483 observations | 1x |
| ISO 13485:2016 Clause 8.5.2 | Cited across public-safe Form 483 observations | 1x |
Full site report
Get the verbatim findings behind Sanmina Ireland Unlimited Company's 2 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