Overview
- 7 FDA inspections are on record.
- 2 inspections produced a Form 483.
- The most recent recorded inspection date is 2026-06-23.
At a glance
Inspections
7
Form 483s
2
EIRs
0
Last outcome
Clean
Inspection history
FDA inspections on record, most recent first.
| Inspection | Category | Outcome | Form 483 |
|---|---|---|---|
| 1 Jun 2026 – 23 Jun 2026 | Medical Devices & Rad Health | Clean | |
| 2 Oct 2017 – 5 Oct 2017 | Medical Devices & Rad Health | 483 | On file |
| 13 Dec 2016 – 14 Dec 2016 | Medical Devices & Rad Health | Clean | |
| 1 Nov 2016 – 10 Nov 2016 | Medical Devices & Rad Health | Clean | |
| 26 Aug 2015 – 28 Aug 2015 | Medical Devices & Rad Health | 483 | View 483 → |
| 11 Sep 2013 | Medical Devices & Rad Health | Clean | |
| 18 Nov 2003 | Not recorded | Clean |
Observations on record
Form 483 observations cited at this site, most recent first.
Investigators
FDA investigators tied to this site in the record.
Jenny L Chisem1 insp.
Adam J Ruben1 insp.
MDSAP WilliamsA1 insp.
Greg K Keshishyan1 insp.
Kelvin Cheung1 insp.
Stephen R Souza1 insp.
Leonard H Lavi1 insp.
Recurring citations
CFR citation patterns observed across this site's inspections.
| Citation | What it covers | Cited |
|---|---|---|
| 21 CFR 803.17(a)(1) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.100(a) | Cited across public-safe Form 483 observations | 2x |
| 21 CFR 820.30(e) | Cited across public-safe Form 483 observations | 2x |
Full site report
Get the verbatim findings behind Illumina, Inc.'s 2 Form 483s
Source PDFs, verbatim observations, 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